By Cara Matthews •Albany Bureau • June 19, 2010, 7:20 pm
ALBANY -- A proposal to flip New York's organ-donation system on its head by presuming people are donors unless they indicate otherwise has the state Legislature buzzing.
Polls have found that the majority of New Yorkers would like to be donors, yet just 13 percent of residents 18 and older are on the state Donate Life Registry. More than 9,600 people in the state need organ transplants, according to the New York Organ Donor Network. Last year, there were just 423 deceased organ donors in New York.
"What we have in New York is a completely failed system," said Assemblyman Richard Brodsky, D-Greenburgh, whose daughter is a two-time kidney transplant recipient and who proposed the legislation.
"People are dying in New York this week because we have failed to create a system that maximizes the opportunities to keep them alive," Brodsky said.
Brodsky said his bills to implement "presumed consent" and prohibit family members from overriding donors' wishes have sparked a lot of interest. People approach him about it everywhere he goes, and individuals and religious groups have raised legitimate concerns.
Because of that, he's not pushing the proposal this session, he said.
"What I've said to anybody, whether they like it or they don't like it, we can't sustain the current system," said Brodsky, whose daughter, Julianne "Willie," received her second transplant four years ago and has become an advocate for changing the system.
He is working on other reforms on organ donations, such as requiring the state Department of Motor Vehicles to provide information on organ donations and creating an organ donation tax credit.
Brodsky, a candidate for state attorney general, co-sponsored legislation this session that would let people consent for giving an anatomical gift through an electronic signature. It passed both houses and goes to Gov. David Paterson for his consideration. Forty-five states allow electronic signatures for donor registries, the New York Organ Donor Network said.
Other states with low donor-registration rates are Texas (an estimated 2 percent), South Carolina (9 percent) and New Hampshire (10 percent), compared to 73 percent in Alaska, an April Donate Life America report found.
No states have "presumed consent" laws, although there have been attempts in several of them, including Maryland and Pennsylvania. Legislation is under consideration in Illinois. A bill was introduced in the Delaware Legislature two years ago.
A number of European nations, including France, Austria and Spain, have this kind of system in place, and they have seen an increase in organ availability, said Arthur Caplan, a bioethics professor at the University of Pennsylvania School of Medicine.
Polla have found that the majority of New Yorkers and Americans want to donate organs and tissues when they die, so the burden should be on the minority to opt out, Caplan said. A recent survey by the New York Alliance for Donation found 67 percent of state residents strongly support organ and tissue donation.
The use of the term "presumed consent" can make some people angry because they don't want presumptions made about what happens to their bodies after they die, Caplan said. He prefers to call it "default to donation."
To get traction in this country, "It's going to take one state to sort of jump out there and show that it works," said Caplan, who has been working on the issue since 1983.
Organ-donation groups report that common objections to presumed consent are a belief that physicians may not work as hard to save them and the government and health care systems would have too much power.
The Long Island Coalition for Life Inc. opposes Brodsky's legislation, which is sponsored in the Senate by Senate Health Committee Chairman Thomas Duane, D-Manhattan.
"This legislation opens up the door to abuse via hastened death of vulnerable people and overriding of family concerns," Jerome Higgins, chairman of the coalition, wrote in a memo to lawmakers. "It also goes a step further toward turning human organs into commodities. The sick and disabled need to be protected, not exploited for their body parts."
The Rev. Jason McGuire of New Yorkers for Constitutional Freedoms, an evangelical Christian group, said organ donation should be voluntary. There are personal-privacy and big-government issues involved. In general, evangelical Christians don't oppose organ donations, although they are not permitted in certain religions, he said.
It's "bizarre" to think presumed consent would go over well with ordinary Americans, said Mary Ann Baily, a fellow of the Hastings Center, a bioethics research group in Garrison, Putnam County, and a graduate faculty member at Sarah Lawrence College in Yonkers. They are frustrated with taxes, and the idea that government would have control over their organs likely is even less popular with them.
"The problem is it's quite easy not to even notice that box that says, 'I don't want to donate my organs,"' she said, referring to a driver's license form. "You should only presume consent when it really is clear that everybody would consent if they thought about it."
One of the major reasons for not having enough organs is people have to die in a certain way and in a hospital for their organs to be viable for use by others. Most families will give consent if they are asked in the right way, said Baily, who once sat on an Institute of Medicine committee that looked at how to boost organ donations.
But even if all available organs were taken, it wouldn't eliminate waiting lists, Baily said. Hospitals may not get the maximum number of organs possible if they and organ banks aren't well organized, she said.
"This law, it seems to me ... is going to stir everybody up and probably not increase organ donations," she said.
Physicians who conduct transplants "don't hope for somebody to die to be a donor," said Dr. Luca Cicalese, chairman and director of the Texas Transplant Center and surgery professor at the University of Texas Medical Branch.
"The reality of the system is that we don't have anything to do with donors," he said.
Transplant staff don't talk to the family of someone who is dying, Cicalese said. That's done by organ-bank staff members, he said.
"There is a system that is very careful in keeping things separate and avoiding conflicts of interest," he said.
Under presumed consent, the family would still be asked whether they wanted the relative's organs to be donated, Cicalese said.
"I think the education is very important. Many people don't understand that one donor can actually save many, many people's lives," he said.
http://www.pressconnects.com/article/20100619/NEWS01/6190348/1112/-Presumed-consent--legislative-proposal-for-organ-donations-sparks-debate
June 19, 2010
At Cao's Request, House Committee Holds Hearing on Viral Hepatitis, "the Secret Epidemic"
At the request of Congressman Anh "Joseph" Cao (LA-02), the House Committee on Oversight and Government Reform held a hearing today on "Viral Hepatitis: the Secret Epidemic"
Publish Date: 2010-06-19
Click here to view related Website: U.S. Congressman Joseph Cao
(From PoliticalNews.me)
WASHINGTON - At the request of Congressman Anh "Joseph" Cao (LA-02), the House Committee on Oversight and Government Reform held a hearing today on "Viral Hepatitis: the Secret Epidemic."
Public health records show viral hepatitis, which is transmitted mainly through contact with infected blood, is the most common blood borne infection in the United States, and it is the nation's leading cause of liver cancer and liver transplants, representing one of the largest and costliest disease burdens. Over the next decade, about 150,000 Americans will die from liver cancer and end-stage liver disease associated with chronic hepatitis B and C.
In prepared remarks submitted for the record, Cao pointed out that between 3.5 to 5.3 million Americans--about 1% to 2% of the population--are infected with viral hepatitis. In Louisiana, some 80,000 people--about 1.8 percent of the population--have hepatitis C. Approximately 20,000 people have hepatitis B and 4.6% of adults are considered at risk.
In New Orleans and Jefferson Parish, about half of hepatitis B patients are Asian Americans in contrast to only 5% of the overall population. Among African Americans, rates of hepatitis C are twice the national average.
Cao said, "This is a grave public health crisis and human tragedy, especially given the asymptomatic nature of the disease, as 65% to 75% of individuals living with viral hepatitis are unaware they are infected until they develop symptoms of liver disease and cancer years later." Cao pointed out that only about half of the cases of hepatitis C in Louisiana are detected for inclusion on the state's hepatitis register.
Witnesses testifying at today's hearing included Congressman Hank Johnson (GA-04), himself a hepatitis C patient, and Congressman Bill Cassidy (LA-06), a leading Louisiana hepatologist.
The committee considered, among other things, a recent Institute of Medicine (IOM) study that found the government has failed to raise awareness, dedicate appropriate resources and properly identify, screen, treat and prevent viral hepatitis.
For example, the administrative budget for the Division of Viral Hepatitis of the Centers for Disease Control and Prevention represents only 2% of the agency's entire budget. Despite projected costs of $16 billion a year nationally, the federal government gives states an average of only $90,000 a year for hepatitis prevention in adults. This provides for little more than one staff position's salary and does not fund any actual services.
The report concluded that the federal government's "current approach to the prevention and control of chronic hepatitis B and hepatitis C is not working." The IOM attributed the lack of knowledge and awareness among the American public and health providers, the large health disparities, and the high mortality rates to the lack of dedicated resources and national leadership.
Cao said, "By calling attention to viral hepatitis at the Congressional level, we hope to focus attention on this 'secret epidemic' and channel resources toward its prevention, more effective treatmen and cure."
http://bignews.biz/?id=886175&keys=Congressman-Joseph-Cao-HepatitisB
Publish Date: 2010-06-19
Click here to view related Website: U.S. Congressman Joseph Cao
(From PoliticalNews.me)
WASHINGTON - At the request of Congressman Anh "Joseph" Cao (LA-02), the House Committee on Oversight and Government Reform held a hearing today on "Viral Hepatitis: the Secret Epidemic."
Public health records show viral hepatitis, which is transmitted mainly through contact with infected blood, is the most common blood borne infection in the United States, and it is the nation's leading cause of liver cancer and liver transplants, representing one of the largest and costliest disease burdens. Over the next decade, about 150,000 Americans will die from liver cancer and end-stage liver disease associated with chronic hepatitis B and C.
In prepared remarks submitted for the record, Cao pointed out that between 3.5 to 5.3 million Americans--about 1% to 2% of the population--are infected with viral hepatitis. In Louisiana, some 80,000 people--about 1.8 percent of the population--have hepatitis C. Approximately 20,000 people have hepatitis B and 4.6% of adults are considered at risk.
In New Orleans and Jefferson Parish, about half of hepatitis B patients are Asian Americans in contrast to only 5% of the overall population. Among African Americans, rates of hepatitis C are twice the national average.
Cao said, "This is a grave public health crisis and human tragedy, especially given the asymptomatic nature of the disease, as 65% to 75% of individuals living with viral hepatitis are unaware they are infected until they develop symptoms of liver disease and cancer years later." Cao pointed out that only about half of the cases of hepatitis C in Louisiana are detected for inclusion on the state's hepatitis register.
Witnesses testifying at today's hearing included Congressman Hank Johnson (GA-04), himself a hepatitis C patient, and Congressman Bill Cassidy (LA-06), a leading Louisiana hepatologist.
The committee considered, among other things, a recent Institute of Medicine (IOM) study that found the government has failed to raise awareness, dedicate appropriate resources and properly identify, screen, treat and prevent viral hepatitis.
For example, the administrative budget for the Division of Viral Hepatitis of the Centers for Disease Control and Prevention represents only 2% of the agency's entire budget. Despite projected costs of $16 billion a year nationally, the federal government gives states an average of only $90,000 a year for hepatitis prevention in adults. This provides for little more than one staff position's salary and does not fund any actual services.
The report concluded that the federal government's "current approach to the prevention and control of chronic hepatitis B and hepatitis C is not working." The IOM attributed the lack of knowledge and awareness among the American public and health providers, the large health disparities, and the high mortality rates to the lack of dedicated resources and national leadership.
Cao said, "By calling attention to viral hepatitis at the Congressional level, we hope to focus attention on this 'secret epidemic' and channel resources toward its prevention, more effective treatmen and cure."
http://bignews.biz/?id=886175&keys=Congressman-Joseph-Cao-HepatitisB
Groundbreaking Drug-Free Treatment for Hepatitis C
By Radha McLean Havana : Cuba
Jun 19, 2010
A potentially groundbreaking study has shown that a nutritional supplement was effective in treating patients with hepatitis C who do not respond to standard antiviral therapy. The research, published in the June 7, 2010 issue of the World Journal of Gastroenterology, was conducted by doctors at the National Institute of Gastroenterology in Havana, Cuba.
Called Viusid, the supplement contains ascorbic acid (vitamin C), zinc, and glycyrrhizic acid (licorice). The antioxidant properties of these ingredients work by preventing the proliferation of free radicals, and their immunomodulatory effects help strengthen the immune system.
Patients with hepatitis C who did not respond to standard therapy received either 3 doses of Viusid daily or placebo. Certain chemicals in the body that gauge levels of oxidative stress and immune response were measured. Patients on Viusid showed significant improvement in these parameters when compared to the control group.
Unfortunately, only 50% of people with hepatitis C respond to the single treatment currently available—the combination of the drugs peginterferon and ribavirin. Trials for other drugs had to be stopped due to serious side effects, the researchers explained in their paper.
“Hepatitis C virus infection is one of the most important causes of chronic liver disease,” stated the authors. “There is an obvious need for the continuous development of new treatment strategies.”
http://www.allvoices.com/contributed-news/6114907-groundbreaking-drugfree-treatment-for-hepatitis-c
Jun 19, 2010
A potentially groundbreaking study has shown that a nutritional supplement was effective in treating patients with hepatitis C who do not respond to standard antiviral therapy. The research, published in the June 7, 2010 issue of the World Journal of Gastroenterology, was conducted by doctors at the National Institute of Gastroenterology in Havana, Cuba.
Called Viusid, the supplement contains ascorbic acid (vitamin C), zinc, and glycyrrhizic acid (licorice). The antioxidant properties of these ingredients work by preventing the proliferation of free radicals, and their immunomodulatory effects help strengthen the immune system.
Patients with hepatitis C who did not respond to standard therapy received either 3 doses of Viusid daily or placebo. Certain chemicals in the body that gauge levels of oxidative stress and immune response were measured. Patients on Viusid showed significant improvement in these parameters when compared to the control group.
Unfortunately, only 50% of people with hepatitis C respond to the single treatment currently available—the combination of the drugs peginterferon and ribavirin. Trials for other drugs had to be stopped due to serious side effects, the researchers explained in their paper.
“Hepatitis C virus infection is one of the most important causes of chronic liver disease,” stated the authors. “There is an obvious need for the continuous development of new treatment strategies.”
http://www.allvoices.com/contributed-news/6114907-groundbreaking-drugfree-treatment-for-hepatitis-c
Exalenz shares soar on liver trial results: Early diagnosis of cirrhosis is important, because it greatly improves treatment
6/13/10 - Exalenz Bioscience Ltd. (TASE:EXEN) has successfully completed the feasibility study to test the effectiveness of its BreathID device to diagnose the severity of liver disease in people with Hepatitis B. The trial was carried out at the Prince of Wales University Hospital in Hong Kong.
Exalenz's share price rose 12.6 percent by midday today to NIS 0.95, giving a market cap of NIS 102 million.
The trial included 47 patients. The BreathID device was able to distinguish between patients in early stages of cirrhosis of the liver and patients with late-stage cirrhosis with an accuracy of 91 percent. Early diagnosis of cirrhosis is important, because it greatly improves treatment and the patients and medical teams' ability to deal with the disease.
The company intends to expand the study to 100 patients, in order to demonstrate the effectiveness of the BreathID device in predicting clinical results.
The BreathID system can assess a range of liver and gastrointestinal disorders by molecular analysis of patients' exhaled breath. It uses a laser-like light source to pinpoint real-time changes in carbon 13-carbon 12 isotope ratios at an accuracy level of single parts per million.
Exalenz cautioned that the test results are insufficient to know whether it can commercialize the BreathID device in the US, Asia, or anywhere else. Commercialization will be dependent on successful clinical trials and the obtaining of regulator permits.
http://www.pharmacychoice.com/News/article.cfm?Article_ID=591824
Exalenz's share price rose 12.6 percent by midday today to NIS 0.95, giving a market cap of NIS 102 million.
The trial included 47 patients. The BreathID device was able to distinguish between patients in early stages of cirrhosis of the liver and patients with late-stage cirrhosis with an accuracy of 91 percent. Early diagnosis of cirrhosis is important, because it greatly improves treatment and the patients and medical teams' ability to deal with the disease.
The company intends to expand the study to 100 patients, in order to demonstrate the effectiveness of the BreathID device in predicting clinical results.
The BreathID system can assess a range of liver and gastrointestinal disorders by molecular analysis of patients' exhaled breath. It uses a laser-like light source to pinpoint real-time changes in carbon 13-carbon 12 isotope ratios at an accuracy level of single parts per million.
Exalenz cautioned that the test results are insufficient to know whether it can commercialize the BreathID device in the US, Asia, or anywhere else. Commercialization will be dependent on successful clinical trials and the obtaining of regulator permits.
http://www.pharmacychoice.com/News/article.cfm?Article_ID=591824
Running To Keep Memory Alive
Annual Tim Harmon Memorial 5K Run/Walk set for June 26.
By Bonnie Hobbs/The Connection
Wednesday, June 16, 2010
When people think of the Fairfax County Government Center, they don’t normally picture people competing in a foot race. But for the past decade, it’s been the site of the Tim Harmon Memorial 5K Run/Walk.
Now, it’s again time for the 11th annual race honoring a former county employee and raising money toward a cure for Hepatitis C. It’s slated for Saturday, June 26 at 8:30 a.m., rain or shine, and signups are still open. Cost is $25, and registration is at www.racepacket.com, or in person on race day, from 7-8:15 a.m.
“It’s nice to do a race at the Government Center because parking is right there,” said race director Tom Cook of Chantilly's Armfield Farm community. “You can walk to the starting line.”
The course is mostly flat and fast, beginning and ending in front of the Government Center and going out to West Ox Road and Monument Drive. Participants may either walk or run. For more information, call 703-934-8756, e-mail peggy.cook@fairfaxcounty.gov or see http://www.timharmon5k.org/ .
Harmon died of Hepatitis C in 1999 at age 51. But before then, he did all he could to help people struggling with addiction. He worked 20 years for Fairfax County and was Director of Residential Services for Alcohol and Drug Services [ADS].
He also founded a substance-abuse treatment program for teens. Because of his efforts, seven new residential treatment programs were opened. He also helped expand those at A New Beginning and Fairfax Detox in Chantilly, New Generations in Vienna, plus Crossroads and Sunrise House.
"Tim hired me in 1984 as a substance-abuse counselor [for ADS]," said Cook, who still holds that position and works with teens. "He was a driving force behind many of this county’s services."
The race is run to remember Harmon and to raise awareness of hepatitis C. Proceeds go to charities including the Hepatitis Foundation, the American Liver Foundation and local drug-treatment centers, including Sunrise in Fair Oaks. Harmon left behind a wife and two daughters, now grown, plus a 10-year-old grandson he never saw. Matthew was born the year after he died; but each year, he participates in the race.
Prizes in the 5K are awarded to the top three, male and female overall finishers, plus the top three finishers in 14 age groups in five-year increments. The race has four divisions: runners/walkers, Fairfax County employees, baby joggers and public safety. Fire and police personnel will compete against each other for team and individual trophies.
Registered participants receive custom T-shirts designed by Kay Rankin. They’re white and adorned with a replica of a running shoe in the Hepatitis Foundation’s colors of yellow and red. “Kay does a great job, every year,” said Cook.
Sports Plus & Battlefield Screen, CASSADAY Inc., MicroPact Engineering, Olympus Auto Parts and Inova Comprehensive Addiction Treatment Services are the major sponsors. More than 100 trophies, plaques and medals will be presented, plus doorprizes from local restaurants and merchants.
They include, goody bags from Starbucks and gift certificates from Potomac River Running Store, Ledo Pizza, Panera, Applebee’s, Bungalow Billiards & Brew, Buffalo Wing Factory, Alexander de Paris, Bristow Manor Golf Course, Wegmans, Guapo’s, Ned Devine’s and Pinecrest Golf Course.
Silent auction items include signed footballs by Brian Griese of the Tampa Bay Buccaneers and his father Bob Griese, the Hall of Fame quarterback from the Miami Dolphins; a hockey puck signed by Washington Capital Matt Bradley; and lots of Washington Redskins memorabilia, including a signed, autographed picture of Redskins greats Art Monk and Darrell Green being inducted into the Hall of Fame.
Bidders can also bid on a mini football helmet signed by Redskins linemen, the Hogs; photos of Redskins Jeff Bostic and Joe Jacoby; a full-size football helmet signed by Randy White (ex-Dallas Cowboy and University of Maryland lineman); and running batons signed by great American distance runners, Bill Rodgers and Joan Benoit-Samuelson.
Adding to the day’s fun is a live, classic-rock band, The Sock Monkeys, who'll entertain before, during and after the race. Post-race refreshments such as bagels, granola bars, juice and soda will be available, and Piedmont School of Massage will give free massages after the race to the runners.
"Last year, we raised almost $13,000 and had 650 participants," said Cook.
"We start working on it in January, and a lot of the race-committee members are county employees who worked with Tim. I run races, too, so I spend April, May and June handing out flyers at other races in which I’m running.”
Cook has been running since high school. “This is one of my passions outside of work,” he said. “We get a lot of positive feedback on the Tim Harmon 5K. I feel good when I hand a flyer to someone and get compliments from people who’ve done this race previously and really liked it. We get lots of repeat customers.”
Literature in the race packets educates people about hepatitis C and how to avoid contracting It. Harmon's disease was discovered through a routine blood test, but no cure is available. It has no symptoms, so people don't realize they have it until they're diagnosed. But by then, their livers may be irreparably damaged and that's what happened to Harmon. For more information, call 1-800-891-0707 or see www.hepfi.org.
“Over 4 million people in the U.S. have been infected with the virus, but as many as half of them do not know they’ve been infected,” said Cook. “At least 75 percent of those infected develop chronic hepatitis, and 30 percent of them go on to develop cirrhosis of the liver. Chronic liver disease due to Hepatitis C causes 20,000 deaths each year in the United States, alone."
That’s why Cook’s pleased that all the proceeds from the Tim Harmon 5K are donated to charity. “We’ve probably raised about $125,000, over 10 years, and that’s a pretty good chunk of change,” said Cook.
http://www.connectionnewspapers.com/article.asp?article=341561&paper=61&cat=104
By Bonnie Hobbs/The Connection
Wednesday, June 16, 2010
When people think of the Fairfax County Government Center, they don’t normally picture people competing in a foot race. But for the past decade, it’s been the site of the Tim Harmon Memorial 5K Run/Walk.
Now, it’s again time for the 11th annual race honoring a former county employee and raising money toward a cure for Hepatitis C. It’s slated for Saturday, June 26 at 8:30 a.m., rain or shine, and signups are still open. Cost is $25, and registration is at www.racepacket.com, or in person on race day, from 7-8:15 a.m.
“It’s nice to do a race at the Government Center because parking is right there,” said race director Tom Cook of Chantilly's Armfield Farm community. “You can walk to the starting line.”
The course is mostly flat and fast, beginning and ending in front of the Government Center and going out to West Ox Road and Monument Drive. Participants may either walk or run. For more information, call 703-934-8756, e-mail peggy.cook@fairfaxcounty.gov or see http://www.timharmon5k.org/ .
Harmon died of Hepatitis C in 1999 at age 51. But before then, he did all he could to help people struggling with addiction. He worked 20 years for Fairfax County and was Director of Residential Services for Alcohol and Drug Services [ADS].
He also founded a substance-abuse treatment program for teens. Because of his efforts, seven new residential treatment programs were opened. He also helped expand those at A New Beginning and Fairfax Detox in Chantilly, New Generations in Vienna, plus Crossroads and Sunrise House.
"Tim hired me in 1984 as a substance-abuse counselor [for ADS]," said Cook, who still holds that position and works with teens. "He was a driving force behind many of this county’s services."
The race is run to remember Harmon and to raise awareness of hepatitis C. Proceeds go to charities including the Hepatitis Foundation, the American Liver Foundation and local drug-treatment centers, including Sunrise in Fair Oaks. Harmon left behind a wife and two daughters, now grown, plus a 10-year-old grandson he never saw. Matthew was born the year after he died; but each year, he participates in the race.
Prizes in the 5K are awarded to the top three, male and female overall finishers, plus the top three finishers in 14 age groups in five-year increments. The race has four divisions: runners/walkers, Fairfax County employees, baby joggers and public safety. Fire and police personnel will compete against each other for team and individual trophies.
Registered participants receive custom T-shirts designed by Kay Rankin. They’re white and adorned with a replica of a running shoe in the Hepatitis Foundation’s colors of yellow and red. “Kay does a great job, every year,” said Cook.
Sports Plus & Battlefield Screen, CASSADAY Inc., MicroPact Engineering, Olympus Auto Parts and Inova Comprehensive Addiction Treatment Services are the major sponsors. More than 100 trophies, plaques and medals will be presented, plus doorprizes from local restaurants and merchants.
They include, goody bags from Starbucks and gift certificates from Potomac River Running Store, Ledo Pizza, Panera, Applebee’s, Bungalow Billiards & Brew, Buffalo Wing Factory, Alexander de Paris, Bristow Manor Golf Course, Wegmans, Guapo’s, Ned Devine’s and Pinecrest Golf Course.
Silent auction items include signed footballs by Brian Griese of the Tampa Bay Buccaneers and his father Bob Griese, the Hall of Fame quarterback from the Miami Dolphins; a hockey puck signed by Washington Capital Matt Bradley; and lots of Washington Redskins memorabilia, including a signed, autographed picture of Redskins greats Art Monk and Darrell Green being inducted into the Hall of Fame.
Bidders can also bid on a mini football helmet signed by Redskins linemen, the Hogs; photos of Redskins Jeff Bostic and Joe Jacoby; a full-size football helmet signed by Randy White (ex-Dallas Cowboy and University of Maryland lineman); and running batons signed by great American distance runners, Bill Rodgers and Joan Benoit-Samuelson.
Adding to the day’s fun is a live, classic-rock band, The Sock Monkeys, who'll entertain before, during and after the race. Post-race refreshments such as bagels, granola bars, juice and soda will be available, and Piedmont School of Massage will give free massages after the race to the runners.
"Last year, we raised almost $13,000 and had 650 participants," said Cook.
"We start working on it in January, and a lot of the race-committee members are county employees who worked with Tim. I run races, too, so I spend April, May and June handing out flyers at other races in which I’m running.”
Cook has been running since high school. “This is one of my passions outside of work,” he said. “We get a lot of positive feedback on the Tim Harmon 5K. I feel good when I hand a flyer to someone and get compliments from people who’ve done this race previously and really liked it. We get lots of repeat customers.”
Literature in the race packets educates people about hepatitis C and how to avoid contracting It. Harmon's disease was discovered through a routine blood test, but no cure is available. It has no symptoms, so people don't realize they have it until they're diagnosed. But by then, their livers may be irreparably damaged and that's what happened to Harmon. For more information, call 1-800-891-0707 or see www.hepfi.org.
“Over 4 million people in the U.S. have been infected with the virus, but as many as half of them do not know they’ve been infected,” said Cook. “At least 75 percent of those infected develop chronic hepatitis, and 30 percent of them go on to develop cirrhosis of the liver. Chronic liver disease due to Hepatitis C causes 20,000 deaths each year in the United States, alone."
That’s why Cook’s pleased that all the proceeds from the Tim Harmon 5K are donated to charity. “We’ve probably raised about $125,000, over 10 years, and that’s a pretty good chunk of change,” said Cook.
http://www.connectionnewspapers.com/article.asp?article=341561&paper=61&cat=104
Red Cross Blood Collection Errors Result in $16M Fine from FDA
Published: June 18th, 2010
The American Red Cross has been fined more than $16 million by the FDA for violating federal regulations on collection and manufacturing of blood products.
The FDA announced that it was fining the American Red Cross for a number of violations of federal laws, as well as for violating a 2003 consent decree between the Red Cross and FDA that was reached after the company was previously fined for blood collection errors. However, the FDA said that despite the violations and the fines, inspectors never found any evidence that the Red Cross endangered patients or the nation’s blood supply.
The Red Cross’s fines total $16.18 million; including $9.79 million in fines for the mismanagement of blood products, and $6.39 million in fines for violating Good Manufacturing Practices. The violations came as a result of 12 FDA inspections conducted since February 2008 at Red Cross facilities across the country.
FDA inspectors found that on a number of occasions the Red Cross failed to promptly conduct adequate investigations, failed to develop and implement adequate corrective actions to resolve problems, and failed to ensure that problems did not reoccur.
Specifically, inspectors found instances of blood components or whole blood number mix-ups, and failure to properly track suspect blood or blood components. Suspect blood components are blood products which could carry the risk of a bloodborne disease or infection that could be transmitted to recipients of blood products, such as HIV or Hepatitis C. The suspect blood products were not distributed, according to inspection report letters sent by FDA to Red Cross.
The fines were assessed under a 2003 consent decree between FDA and Red Cross, reached between the agency and the non-profit organization after similar problems were discovered in 1993. The consent decree allows the FDA to impose significant fines on Red Cross when the organization fails to comply with federal blood collection regulations. Before the most recent fines, the Red Cross has been fined about $21 million by FDA since the consent decree.
http://www.aboutlawsuits.com/fda-fines-red-cross-blood-collection-errors-10911/
The American Red Cross has been fined more than $16 million by the FDA for violating federal regulations on collection and manufacturing of blood products.
The FDA announced that it was fining the American Red Cross for a number of violations of federal laws, as well as for violating a 2003 consent decree between the Red Cross and FDA that was reached after the company was previously fined for blood collection errors. However, the FDA said that despite the violations and the fines, inspectors never found any evidence that the Red Cross endangered patients or the nation’s blood supply.
The Red Cross’s fines total $16.18 million; including $9.79 million in fines for the mismanagement of blood products, and $6.39 million in fines for violating Good Manufacturing Practices. The violations came as a result of 12 FDA inspections conducted since February 2008 at Red Cross facilities across the country.
FDA inspectors found that on a number of occasions the Red Cross failed to promptly conduct adequate investigations, failed to develop and implement adequate corrective actions to resolve problems, and failed to ensure that problems did not reoccur.
Specifically, inspectors found instances of blood components or whole blood number mix-ups, and failure to properly track suspect blood or blood components. Suspect blood components are blood products which could carry the risk of a bloodborne disease or infection that could be transmitted to recipients of blood products, such as HIV or Hepatitis C. The suspect blood products were not distributed, according to inspection report letters sent by FDA to Red Cross.
The fines were assessed under a 2003 consent decree between FDA and Red Cross, reached between the agency and the non-profit organization after similar problems were discovered in 1993. The consent decree allows the FDA to impose significant fines on Red Cross when the organization fails to comply with federal blood collection regulations. Before the most recent fines, the Red Cross has been fined about $21 million by FDA since the consent decree.
http://www.aboutlawsuits.com/fda-fines-red-cross-blood-collection-errors-10911/
Studies Analyze Shellfish Safety
http://www.foodsafetynews.com/
by Alexa Nemeth
Two new studies on viral pathogens in oysters and mollusks shed new light on the need for better detection methods and treatments that are needed to ensure shellfish safety.
Over the past few years both the United States and Europe have reported several foodborne illness outbreaks related to contaminated oysters and other mollusks.
The first study, by Spanish researchers, appeared in Emerging Infectious Diseases (EID). In it, scientists analyzed 50 mollusk samples imported into Spain from Sep 2006 to Mar 2009 for the presence of three human enteric viruses, including two norovirus genotypes, hepatitis A, and astrovirus. Species included clams, oysters, cockles, and razor clams. The mollusks were imported from Morocco, Peru, Vietnam, and South Korea.
According to the Center for Infectious Disease Research and Policy, real-time reverse transcription polymerase chain reaction (RT-PCR) testing was used to detect norovirus and hepatitis A and standard RT-PCR was used to detect astrovirus.
Researchers found that 40 percent of the 50 samples were contaminated by at least one virus, though they all had met current food safety standards. Present in 24 percent of samples was norovirus genotype 1, followed by astrovirus--found in 18 percent of samples, norovirus genotype 2--found in 8 percent, and hepatitis A.
Six of the positive samples tested positive for more than one virus. The authors noted that infections with multiple virus strains could produce more severe symptoms and possibly lead to the emergence of new recombinant strains.
The researchers recognized the difficulty of detecting and monitoring viral contamination in shellfish samples, however, they believe the new prevention strategies based on microbiological risk assessment could help ensure product safety and that it's essential to implement such steps and provide good lab training in developing countries that export the products.
In the second study, which appears in Eurosurveillance, Irish researchers reported on a method they tested to reduce possible oyster contamination in harvesting areas linked to gastroenteritis outbreaks. The research team noted that methods for detecting norovirus in shellfish are relatively new and that processes to eliminate bacteria in oysters--putting them in clean seawater at ambient temperatures so they can purge their contaminants--do little to reduce virus levels in oysters.
Oysters from an Irish harvesting area linked to norovirus outbreaks were used to test a modified "depuration" method involving the re-laying of oysters in clean areas for 17 days, then subjecting them to elevated water temperatures (15C to 17C) for at least 4 days.
The researchers reported that after treatment, norovirus levels in the re-laid oysters decreased from 2,900 to 492 genome copies. Exposing them to the higher temperatures for 4 days reduced norovirus levels to 136 viral genome copies. The level fell below assay detection at 6 days.
The group concluded that growing evidence suggests that it is possible to gauge illness risk based on norovirus levels in oysters and that given the inadequacy of existing controls to prevent contamination, setting an appropriate virus standard would yield public health benefits.
They also wrote that validated treatment processes can be used to produce a safe product, even when low levels of norovirus are detected in the treated oysters.
http://www.hcvadvocate.org/news/newsRev/2010/NewsRev-366.html#_Studies_Analyze_Shellfish
by Alexa Nemeth
Two new studies on viral pathogens in oysters and mollusks shed new light on the need for better detection methods and treatments that are needed to ensure shellfish safety.
Over the past few years both the United States and Europe have reported several foodborne illness outbreaks related to contaminated oysters and other mollusks.
The first study, by Spanish researchers, appeared in Emerging Infectious Diseases (EID). In it, scientists analyzed 50 mollusk samples imported into Spain from Sep 2006 to Mar 2009 for the presence of three human enteric viruses, including two norovirus genotypes, hepatitis A, and astrovirus. Species included clams, oysters, cockles, and razor clams. The mollusks were imported from Morocco, Peru, Vietnam, and South Korea.
According to the Center for Infectious Disease Research and Policy, real-time reverse transcription polymerase chain reaction (RT-PCR) testing was used to detect norovirus and hepatitis A and standard RT-PCR was used to detect astrovirus.
Researchers found that 40 percent of the 50 samples were contaminated by at least one virus, though they all had met current food safety standards. Present in 24 percent of samples was norovirus genotype 1, followed by astrovirus--found in 18 percent of samples, norovirus genotype 2--found in 8 percent, and hepatitis A.
Six of the positive samples tested positive for more than one virus. The authors noted that infections with multiple virus strains could produce more severe symptoms and possibly lead to the emergence of new recombinant strains.
The researchers recognized the difficulty of detecting and monitoring viral contamination in shellfish samples, however, they believe the new prevention strategies based on microbiological risk assessment could help ensure product safety and that it's essential to implement such steps and provide good lab training in developing countries that export the products.
In the second study, which appears in Eurosurveillance, Irish researchers reported on a method they tested to reduce possible oyster contamination in harvesting areas linked to gastroenteritis outbreaks. The research team noted that methods for detecting norovirus in shellfish are relatively new and that processes to eliminate bacteria in oysters--putting them in clean seawater at ambient temperatures so they can purge their contaminants--do little to reduce virus levels in oysters.
Oysters from an Irish harvesting area linked to norovirus outbreaks were used to test a modified "depuration" method involving the re-laying of oysters in clean areas for 17 days, then subjecting them to elevated water temperatures (15C to 17C) for at least 4 days.
The researchers reported that after treatment, norovirus levels in the re-laid oysters decreased from 2,900 to 492 genome copies. Exposing them to the higher temperatures for 4 days reduced norovirus levels to 136 viral genome copies. The level fell below assay detection at 6 days.
The group concluded that growing evidence suggests that it is possible to gauge illness risk based on norovirus levels in oysters and that given the inadequacy of existing controls to prevent contamination, setting an appropriate virus standard would yield public health benefits.
They also wrote that validated treatment processes can be used to produce a safe product, even when low levels of norovirus are detected in the treated oysters.
http://www.hcvadvocate.org/news/newsRev/2010/NewsRev-366.html#_Studies_Analyze_Shellfish
Two week induction of interferon-beta followed by pegylated interferon alpha-2b and ribavirin for chronic infection with hepatitis C
Hepatol Res. 2010 Jun 8. [Epub ahead of print]
Matsui K, Iwabuchi S, Shimizu H, Yoshida A, Fujikawa T, Takatsuka K.
Center for Digestive and Liver Disease, Ofuna Chuo Hospital, Kanagawa, Japan.
Abstract
Objectives: To elucidate the efficacy of interferon (IFN)-beta induction therapy followed by pegylated IFN alpha and ribavirin for chronic infection with hepatitis C virus (HCV). Methods: Patients chronically infected with HCV genotype 1, high titer were enrolled. Twice daily bolus injections of 3 million units IFN-beta were administered for 14 days. Thereafter, weekly injection of pegylated IFN alpha 2b and daily intake of ribavirin were followed. Therapy duration was adjusted according to the response to the therapy. When time to an undetectable HCV-RNA was 1, 2, 4, 8, and 12 weeks, total duration of therapy was 12, 24, 36, 48 and 60 weeks, respectively. Patients who failed to achieve an undetectable HCV-RNA within 12 weeks discontinued therapy on 12 week. Results: Among the 101 patients treated, 56 (55.4%) achieved sustained virological response (SVR). SVR rate for each treatment duration was 10/10 for 12 weeks, 12/14 for 24 weeks, 18/19 for 36 weeks, 15/26 for 48 weeks, 1/4 for 60 weeks and 0/28 for patients who discontinued therapy at 12 weeks. Mean time to an undetectable HCV-RNA was 35.5 +/- 2.7 days. Mean therapy duration was 27.3 +/- 1.4 weeks. Using a cut off value of 21.5 fmol/L of HCV core-antigen in the first week, SVR could be predicted by sensitivity of 0.91 and specificity of 0.78. Conclusion: IFN-beta induction therapy resulted in acceptable SVR rates despite short therapy duration. Steep reduction of HCV by IFN-beta enables us to predict SVR in the first week of therapy.
PMID: 20557368 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20557368
Matsui K, Iwabuchi S, Shimizu H, Yoshida A, Fujikawa T, Takatsuka K.
Center for Digestive and Liver Disease, Ofuna Chuo Hospital, Kanagawa, Japan.
Abstract
Objectives: To elucidate the efficacy of interferon (IFN)-beta induction therapy followed by pegylated IFN alpha and ribavirin for chronic infection with hepatitis C virus (HCV). Methods: Patients chronically infected with HCV genotype 1, high titer were enrolled. Twice daily bolus injections of 3 million units IFN-beta were administered for 14 days. Thereafter, weekly injection of pegylated IFN alpha 2b and daily intake of ribavirin were followed. Therapy duration was adjusted according to the response to the therapy. When time to an undetectable HCV-RNA was 1, 2, 4, 8, and 12 weeks, total duration of therapy was 12, 24, 36, 48 and 60 weeks, respectively. Patients who failed to achieve an undetectable HCV-RNA within 12 weeks discontinued therapy on 12 week. Results: Among the 101 patients treated, 56 (55.4%) achieved sustained virological response (SVR). SVR rate for each treatment duration was 10/10 for 12 weeks, 12/14 for 24 weeks, 18/19 for 36 weeks, 15/26 for 48 weeks, 1/4 for 60 weeks and 0/28 for patients who discontinued therapy at 12 weeks. Mean time to an undetectable HCV-RNA was 35.5 +/- 2.7 days. Mean therapy duration was 27.3 +/- 1.4 weeks. Using a cut off value of 21.5 fmol/L of HCV core-antigen in the first week, SVR could be predicted by sensitivity of 0.91 and specificity of 0.78. Conclusion: IFN-beta induction therapy resulted in acceptable SVR rates despite short therapy duration. Steep reduction of HCV by IFN-beta enables us to predict SVR in the first week of therapy.
PMID: 20557368 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20557368
Viral response to specifically targeted antiviral therapy for hepatitis C and the implications for treatment success
Can J Gastroenterol. 2010 Jun;24(6):385-90.
Cooper C.
Abstract
Currently, hepatitis C virus (HCV) antiviral therapy is characterized by long duration, a multitude of side effects, difficult administration and suboptimal success; clearly, alternatives are needed. Collectively, specifically targeted antiviral therapy for HCV (STAT-C) molecules achieve rapid viral suppression and very high rapid virological response rates, and improve sustained virological response rates. The attrition rate of agents within this class has been high due to various toxicities. Regardless, several STAT-C molecules are poised to become the standard of care for HCV treatment in the foreseeable future. Optimism must be tempered with concerns related to the rapid development of drug resistance with resulting HCV rebound. Strategies including induction dosing with interferon and ribavirin, use of combination high-potency STAT-C molecules and an intensive emphasis on adherence to HCV antiviral therapy will be critical to the success of this promising advance in HCV therapy.
PMID: 20559582 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/20559582
Cooper C.
Abstract
Currently, hepatitis C virus (HCV) antiviral therapy is characterized by long duration, a multitude of side effects, difficult administration and suboptimal success; clearly, alternatives are needed. Collectively, specifically targeted antiviral therapy for HCV (STAT-C) molecules achieve rapid viral suppression and very high rapid virological response rates, and improve sustained virological response rates. The attrition rate of agents within this class has been high due to various toxicities. Regardless, several STAT-C molecules are poised to become the standard of care for HCV treatment in the foreseeable future. Optimism must be tempered with concerns related to the rapid development of drug resistance with resulting HCV rebound. Strategies including induction dosing with interferon and ribavirin, use of combination high-potency STAT-C molecules and an intensive emphasis on adherence to HCV antiviral therapy will be critical to the success of this promising advance in HCV therapy.
PMID: 20559582 [PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/20559582
Indian Spice May Delay Liver Damage and Cirrhosis, Study Suggests
ScienceDaily (Mar. 24, 2010) — Curcumin, one of the principal components of the Indian spice turmeric, seems to delay the liver damage that eventually causes cirrhosis, suggests preliminary experimental research in the journal Gut.
Curcumin, which gives turmeric its bright yellow pigment, has long been used in Indian Ayurvedic medicine to treat a wide range of gastrointestinal disorders.
Previous research has indicated that it has anti-inflammatory and antioxidant properties which may be helpful in combating disease.
The research team wanted to find out if curcumin could delay the damage caused by progressive inflammatory conditions of the liver, including primary sclerosing cholangitis and primary biliary cirrhosis.
Both of these conditions, which can be sparked by genetic faults or autoimmune disease, cause the liver's plumbing system of bile ducts to become inflamed, scarred, and blocked. This leads to extensive tissue damage and irreversible and ultimately fatal liver cirrhosis.
The research team analysed tissue and blood samples from mice with chronic liver inflammation before and after adding curcumin to their diet for a period of four and a period of eight weeks.
The results were compared with the equivalent samples from mice with the same condition, but not fed curcumin.
The findings showed that the curcumin diet significantly reduced bile duct blockage and curbed liver cell (hepatocyte) damage and scarring (fibrosis) by interfering with several chemical signalling pathways involved in the inflammatory process.
These effects were clear at both four and eight weeks. No such effects were seen in mice fed a normal diet.
The authors point out that current treatment for inflammatory liver disease involves ursodeoxycholic acid, the long term effects of which remain unclear. The other alternative is a liver transplant.
Curcumin is a natural product, they say, which seems to target several different parts of the inflammatory process, and as such, may therefore offer a very promising treatment in the future.
Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by BMJ-British Medical Journal, via EurekAlert! a service of AAAS.
Journal Reference:
Anna Baghdasaryan, Thierry Claudel, Astrid Kosters, Judith Gumhold, Dagmar Silbert, Andrea Thüringer, Katharina Leski, Peter Fickert, Saul J Karpen, Michael Trauner. Curcumin improves sclerosing cholangitis in Mdr2-/- mice by inhibition of cholangiocyte inflammatory response and portal myofibroblast proliferation. Gut, 2010; 59: 521-530 DOI: 10.1136/gut.2009.186528
http://www.sciencedaily.com/releases/2010/03/100323212150.htm
Curcumin, which gives turmeric its bright yellow pigment, has long been used in Indian Ayurvedic medicine to treat a wide range of gastrointestinal disorders.
Previous research has indicated that it has anti-inflammatory and antioxidant properties which may be helpful in combating disease.
The research team wanted to find out if curcumin could delay the damage caused by progressive inflammatory conditions of the liver, including primary sclerosing cholangitis and primary biliary cirrhosis.
Both of these conditions, which can be sparked by genetic faults or autoimmune disease, cause the liver's plumbing system of bile ducts to become inflamed, scarred, and blocked. This leads to extensive tissue damage and irreversible and ultimately fatal liver cirrhosis.
The research team analysed tissue and blood samples from mice with chronic liver inflammation before and after adding curcumin to their diet for a period of four and a period of eight weeks.
The results were compared with the equivalent samples from mice with the same condition, but not fed curcumin.
The findings showed that the curcumin diet significantly reduced bile duct blockage and curbed liver cell (hepatocyte) damage and scarring (fibrosis) by interfering with several chemical signalling pathways involved in the inflammatory process.
These effects were clear at both four and eight weeks. No such effects were seen in mice fed a normal diet.
The authors point out that current treatment for inflammatory liver disease involves ursodeoxycholic acid, the long term effects of which remain unclear. The other alternative is a liver transplant.
Curcumin is a natural product, they say, which seems to target several different parts of the inflammatory process, and as such, may therefore offer a very promising treatment in the future.
Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by BMJ-British Medical Journal, via EurekAlert! a service of AAAS.
Journal Reference:
Anna Baghdasaryan, Thierry Claudel, Astrid Kosters, Judith Gumhold, Dagmar Silbert, Andrea Thüringer, Katharina Leski, Peter Fickert, Saul J Karpen, Michael Trauner. Curcumin improves sclerosing cholangitis in Mdr2-/- mice by inhibition of cholangiocyte inflammatory response and portal myofibroblast proliferation. Gut, 2010; 59: 521-530 DOI: 10.1136/gut.2009.186528
http://www.sciencedaily.com/releases/2010/03/100323212150.htm
Understanding the Mechanisms of Liver Regeneration Through Computer Simulation
ScienceDaily (June 9, 2010) — How does the liver manage to regenerate itself even after severe damage? Seeking to find an answer to this significant medical question, scientists of the HepatoSys/German Virtual Liver Network have gained new insights into the underlying processes involved in the regeneration of liver lobules using computer simulation and laboratory experiments.
What that looks like has been demonstrated at the third Conference on Systems Biology of Mammalian Cells (SBMC) from June 3-5, 2010 at the Concert Hall (Konzerthaus) in Freiburg (http://www.sbmc2010.de/). The new perspectives on liver regeneration open the door to developing new treatments for cirrhosis and other injuries to this vital organ.
The singular mechanisms of liver regeneration
The liver is a very special organ: even if more than fifty percent of its overall mass is damaged -- for instance, by intoxication -- it can regenerate itself completely. This amazing ability is essential. The liver is the body's most important metabolic organ and has the task, among others, of detoxifying the blood. To enable it to do this, the liver is equipped with a very complex anatomy: in humans both hepatic lobes are composed of about a million small lobules that are a maximum of one to two millimeters in size.
The blood flowing into the liver enters the lobules via the so-called portal field, which separates neighboring lobules from each other. From there it flows through microvessels surrounded by hepatocytes -- the most common type of cell in the liver -- and drains into a centrally located vein. This special architecture ensures that the blood is brought into optimal contact with the hepatocytes when it flows through the organ.
When a liver has recovered after damage caused by drugs, alcohol consumption or a viral infection, this complex architecture must be restored. The underlying mechanisms are still poorly understood. HepatoSys researchers led by Dirk Drasdo at the Interdisciplinary Centre for Bioinformatics in Leipzig (IZBI) and the French National Institute for Research in Computer Science and Control (INRIA) in Le Chesnay near Paris have started investigating liver regeneration using computer-based methods of systems biology: Drasdo and his team simulated the scenario after intoxication with carbon tetrachloride (CCl4) in mice -- a typical animal model for paracetamol intoxication in humans -- on the computer.
From the tissue section to the computer
The first of three steps was to obtain a computer representation of an average liver lobule. Working closely with the experimental research group led by Jan Hengstler of the Leibniz Institute and the University of Dortmund, the scientists recorded parameters necessary to quantitatively characterize the static lobule architecture, such as the shape and orientation of the blood vessels, and the shape, orientation and spatial organization of the hepatocytes. These parameters were extracted using image processing methods that allow the full three-dimensional reconstruction of microscopic images of specially prepared serial tissue sections, followed by turning the three-dimensional patterns into numbers.
The second step was to record the regeneration process in the liver lobules of mice. The animals were injected with the liver-damaging substance carbon tetrachloride, which -- like paracetamol intoxication -- results in the death of hepatocytes near the central vein of the liver lobule. To characterize the regeneration process quantitatively, the scientists introduced so-called process parameters. These parameters -- also obtained from image analysis -- record when and where new hepatocytes are created and register their movements and alignment within the organ in the process of regenerating the original architecture of the liver lobule.
Finally, based on all these parameters a mathematical model was developed with which the spatial- temporal dynamics of individual hepatocytes and blood vessels could be simulated on a computer. With their computer model the scientists managed to identify previously unrecognized mechanisms during regeneration in liver lobules. As it turned out, the new cells do not just emerge at arbitrary locations within the lobule; "Instead it quickly became evident that the spatio-temporal process can only function properly if the new hepatocytes align themselves along the sinusoids, the micro-blood vessels that traverse the liver lobule," explains Drasdo's co-worker Stefan Höhme. This observation on the basis of the computer model was subsequently confirmed on real liver lobules in a laboratory experiment. "That," according to Höhme, "brings us closer to an understanding of the complex processes involved in liver regeneration."
Not only for the liver
As Drasdo emphasizes, such a dynamic model of a multi-cellular arrangement capable of making correct predictions is still a great exception: "It simultaneously records single cells and the whole tissue," he says. "And that creates the basis for examining in more detail the signalling processes within and among the cells that control regeneration."
The same principle can be applied to build models for other medically relevant questions, e.g. how a tumor spreads to other parts of the body. Understanding these dynamic processes paves the way for new and effective treatments, e.g. to support the liver during the regenerative process or to hinder tumor progression. "Our work was only possible because we were able to work hand in hand with the experimental research group led by Jan Hengstler in Dortmund," emphasized Drasdo, who has many years of experience in modeling cells and cell aggregates. "Only then could we validate the results from our computer simulations directly with an experiment and calibrate our models with experimental data- that is exactly what constitutes systems biology."
Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by HepatoSys/Virtual LIver Network, via AlphaGalileo.
Journal Reference:
S. Hoehme, M. Brulport, A. Bauer, E. Bedawy, W. Schormann, M. Hermes, V. Puppe, R. Gebhardt, S. Zellmer, M. Schwarz, E. Bockamp, T. Timmel, J. G. Hengstler, D. Drasdo. Prediction and validation of cell alignment along microvessels as order principle to restore tissue architecture in liver regeneration. Proceedings of the National Academy of Sciences, 2010; DOI: 10.1073/pnas.0909374107
http://www.sciencedaily.com/releases/2010/06/100607065856.htm
What that looks like has been demonstrated at the third Conference on Systems Biology of Mammalian Cells (SBMC) from June 3-5, 2010 at the Concert Hall (Konzerthaus) in Freiburg (http://www.sbmc2010.de/). The new perspectives on liver regeneration open the door to developing new treatments for cirrhosis and other injuries to this vital organ.
The singular mechanisms of liver regeneration
The liver is a very special organ: even if more than fifty percent of its overall mass is damaged -- for instance, by intoxication -- it can regenerate itself completely. This amazing ability is essential. The liver is the body's most important metabolic organ and has the task, among others, of detoxifying the blood. To enable it to do this, the liver is equipped with a very complex anatomy: in humans both hepatic lobes are composed of about a million small lobules that are a maximum of one to two millimeters in size.
The blood flowing into the liver enters the lobules via the so-called portal field, which separates neighboring lobules from each other. From there it flows through microvessels surrounded by hepatocytes -- the most common type of cell in the liver -- and drains into a centrally located vein. This special architecture ensures that the blood is brought into optimal contact with the hepatocytes when it flows through the organ.
When a liver has recovered after damage caused by drugs, alcohol consumption or a viral infection, this complex architecture must be restored. The underlying mechanisms are still poorly understood. HepatoSys researchers led by Dirk Drasdo at the Interdisciplinary Centre for Bioinformatics in Leipzig (IZBI) and the French National Institute for Research in Computer Science and Control (INRIA) in Le Chesnay near Paris have started investigating liver regeneration using computer-based methods of systems biology: Drasdo and his team simulated the scenario after intoxication with carbon tetrachloride (CCl4) in mice -- a typical animal model for paracetamol intoxication in humans -- on the computer.
From the tissue section to the computer
The first of three steps was to obtain a computer representation of an average liver lobule. Working closely with the experimental research group led by Jan Hengstler of the Leibniz Institute and the University of Dortmund, the scientists recorded parameters necessary to quantitatively characterize the static lobule architecture, such as the shape and orientation of the blood vessels, and the shape, orientation and spatial organization of the hepatocytes. These parameters were extracted using image processing methods that allow the full three-dimensional reconstruction of microscopic images of specially prepared serial tissue sections, followed by turning the three-dimensional patterns into numbers.
The second step was to record the regeneration process in the liver lobules of mice. The animals were injected with the liver-damaging substance carbon tetrachloride, which -- like paracetamol intoxication -- results in the death of hepatocytes near the central vein of the liver lobule. To characterize the regeneration process quantitatively, the scientists introduced so-called process parameters. These parameters -- also obtained from image analysis -- record when and where new hepatocytes are created and register their movements and alignment within the organ in the process of regenerating the original architecture of the liver lobule.
Finally, based on all these parameters a mathematical model was developed with which the spatial- temporal dynamics of individual hepatocytes and blood vessels could be simulated on a computer. With their computer model the scientists managed to identify previously unrecognized mechanisms during regeneration in liver lobules. As it turned out, the new cells do not just emerge at arbitrary locations within the lobule; "Instead it quickly became evident that the spatio-temporal process can only function properly if the new hepatocytes align themselves along the sinusoids, the micro-blood vessels that traverse the liver lobule," explains Drasdo's co-worker Stefan Höhme. This observation on the basis of the computer model was subsequently confirmed on real liver lobules in a laboratory experiment. "That," according to Höhme, "brings us closer to an understanding of the complex processes involved in liver regeneration."
Not only for the liver
As Drasdo emphasizes, such a dynamic model of a multi-cellular arrangement capable of making correct predictions is still a great exception: "It simultaneously records single cells and the whole tissue," he says. "And that creates the basis for examining in more detail the signalling processes within and among the cells that control regeneration."
The same principle can be applied to build models for other medically relevant questions, e.g. how a tumor spreads to other parts of the body. Understanding these dynamic processes paves the way for new and effective treatments, e.g. to support the liver during the regenerative process or to hinder tumor progression. "Our work was only possible because we were able to work hand in hand with the experimental research group led by Jan Hengstler in Dortmund," emphasized Drasdo, who has many years of experience in modeling cells and cell aggregates. "Only then could we validate the results from our computer simulations directly with an experiment and calibrate our models with experimental data- that is exactly what constitutes systems biology."
Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by HepatoSys/Virtual LIver Network, via AlphaGalileo.
Journal Reference:
S. Hoehme, M. Brulport, A. Bauer, E. Bedawy, W. Schormann, M. Hermes, V. Puppe, R. Gebhardt, S. Zellmer, M. Schwarz, E. Bockamp, T. Timmel, J. G. Hengstler, D. Drasdo. Prediction and validation of cell alignment along microvessels as order principle to restore tissue architecture in liver regeneration. Proceedings of the National Academy of Sciences, 2010; DOI: 10.1073/pnas.0909374107
http://www.sciencedaily.com/releases/2010/06/100607065856.htm
Functional, Transplantable Rat Liver Grafts: Discarded Livers Have Potential to Be Reengineered Into Usable Replacement Organs
ScienceDaily (June 15, 2010) — A team led by researchers from the Center for Engineering in Medicine at Massachusetts General Hospital (MGH) has developed a technique that someday may allow growth of transplantable replacement livers. In a study appearing in Nature Medicine, the investigators describe using the structural tissue of rat livers as scaffolding for the growth of tissue regenerated from liver cells introduced through a novel reseeding process.
"Having the detailed microvasculature of the liver within a biocompatible, natural scaffold is a major advantage to growing liver tissue in a synthetic environment," says Basak Uygun, PhD, research associate at the MGH Center for Engineering in Medicine (MGH-CEM) and the paper's lead author. "Our technique of 'decellularizing' organs leaves the vascular system intact, which facilitates repopulation of the structural matrix and the subsequent survival and function of the introduced liver cells."
Liver transplantation is the only effective treatment for liver failure but is greatly limited by the shortage of donor organs. Each year 4,000 individuals who might have survived with a liver transplant die in the U.S. The shortage of donor livers and other organs is a major force behind the emerging field of tissue engineering and regenerative medicine. Efforts to build tissues from the ground up have not yet approached the goal of transplantable replacement organs, and replacing the liver -- in which each cell is a metabolic factory requiring constant, direct contact with the vascular system -- has been particularly challenging.
The current report describes a refinement of an approach to re-engineering replacement rat hearts that was reported in 2008 by University of Minnesota researchers. Since liver tissue is much more delicate than the muscular structure of the heart, the MGH-CEM team developed a gentler way of flushing living cells out of the liver's structural matrix, which is primarily made of connective tissue like collagen. After the cells were removed, the lobular structure of the liver and its extracellular matrix remained. Containing specific biochemical signals and cues that would direct liver cells to travel to the correct location and resume function -- something quite difficult to replicate using synthetic methods -- the matrix also maintained the organ's intricate network of blood vessels.
Another novel technique was used to reintroduce hepatocytes, the cells that carry out most of the liver's primary functions, into the decellularized matrix. The MGH-CEM approach actually caused cells to penetrate the vascular network and become embedded in the matrix, leaving major vessels clear to carry the essential blood supply. The repopulated matrix displayed normal liver function for up to 10 days in culture, and recellularized grafts were successfully connected to the circulation of live rats with minimal cellular damage and normal hepatocyte function.
"As far as we know, a transplantable liver graft has never been constructed in a laboratory setting before," explains Korkut Uygun, PhD, of the MGH-CEM, the paper's senior author. "Even though this is very exciting and promising, it is a proof-of-concept study only. Much more work will be required to make long-term functional liver grafts that can actually be transplanted into humans. We haven't been able to go beyond several hours in the rats, but it's a great start."
Martin Yarmush, MD, PhD, director of the MGH-CEM and a co-author of the Nature Medicine study, explains that the quarter of a million donor livers discarded each year because they are not suitable for transplantation would be an obvious source of supply for the creation of whole-organ scaffolds. "There is great potential for constructing full-fledged liver lobes containing animal or human cells, but several thorny issues must first be tackled, including formation of a layer of endothelial cells to line graft blood vessels," he says. "Given enough careful work, this approach could ultimately revolutionize tissue engineering and provide real working grafts for the liver and other complex tissues." Yarmush and Korkut Uygun both have faculty appointments at Harvard Medical School.
Additional co-authors of the Nature Medicine report are Alejandro Soto-Gutierrez, MD, PhD, Hiroshi Yagi, MD, Maria-Louisa Izamis, Maria Guzzardi, Carley Shulman, Jack Milwid, Arno Tilles, MD, Francois Berthiaume, PhD, and Yaahov Nahmias, PhD, MGH Center for Engineering in Medicine; Martin Hertl, MD, MGH Surgery; and Naoya Kobyashi, MD, PhD, Okayama University School of Medicine and Dentistry, Japan. The study was partially supported by grants from the National Institutes of Health, National Science Foundation and Shriners Hospitals for Children.
Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Massachusetts General Hospital, via EurekAlert! a service of AAAS.
Journal Reference:
Basak E Uygun, Alejandro Soto-Gutierrez, Hiroshi Yagi, Maria-Louisa Izamis, Maria A Guzzardi, Carley Shulman, Jack Milwid, Naoya Kobayashi, Arno Tilles, Francois Berthiaume, Martin Hertl, Yaakov Nahmias, Martin L Yarmush, Korkut Uygun. Organ reengineering through development of a transplantable recellularized liver graft using decellularized liver matrix. Nature Medicine, 2010; DOI: 10.1038/nm.2170
http://www.sciencedaily.com/releases/2010/06/100613181240.htm
"Having the detailed microvasculature of the liver within a biocompatible, natural scaffold is a major advantage to growing liver tissue in a synthetic environment," says Basak Uygun, PhD, research associate at the MGH Center for Engineering in Medicine (MGH-CEM) and the paper's lead author. "Our technique of 'decellularizing' organs leaves the vascular system intact, which facilitates repopulation of the structural matrix and the subsequent survival and function of the introduced liver cells."
Liver transplantation is the only effective treatment for liver failure but is greatly limited by the shortage of donor organs. Each year 4,000 individuals who might have survived with a liver transplant die in the U.S. The shortage of donor livers and other organs is a major force behind the emerging field of tissue engineering and regenerative medicine. Efforts to build tissues from the ground up have not yet approached the goal of transplantable replacement organs, and replacing the liver -- in which each cell is a metabolic factory requiring constant, direct contact with the vascular system -- has been particularly challenging.
The current report describes a refinement of an approach to re-engineering replacement rat hearts that was reported in 2008 by University of Minnesota researchers. Since liver tissue is much more delicate than the muscular structure of the heart, the MGH-CEM team developed a gentler way of flushing living cells out of the liver's structural matrix, which is primarily made of connective tissue like collagen. After the cells were removed, the lobular structure of the liver and its extracellular matrix remained. Containing specific biochemical signals and cues that would direct liver cells to travel to the correct location and resume function -- something quite difficult to replicate using synthetic methods -- the matrix also maintained the organ's intricate network of blood vessels.
Another novel technique was used to reintroduce hepatocytes, the cells that carry out most of the liver's primary functions, into the decellularized matrix. The MGH-CEM approach actually caused cells to penetrate the vascular network and become embedded in the matrix, leaving major vessels clear to carry the essential blood supply. The repopulated matrix displayed normal liver function for up to 10 days in culture, and recellularized grafts were successfully connected to the circulation of live rats with minimal cellular damage and normal hepatocyte function.
"As far as we know, a transplantable liver graft has never been constructed in a laboratory setting before," explains Korkut Uygun, PhD, of the MGH-CEM, the paper's senior author. "Even though this is very exciting and promising, it is a proof-of-concept study only. Much more work will be required to make long-term functional liver grafts that can actually be transplanted into humans. We haven't been able to go beyond several hours in the rats, but it's a great start."
Martin Yarmush, MD, PhD, director of the MGH-CEM and a co-author of the Nature Medicine study, explains that the quarter of a million donor livers discarded each year because they are not suitable for transplantation would be an obvious source of supply for the creation of whole-organ scaffolds. "There is great potential for constructing full-fledged liver lobes containing animal or human cells, but several thorny issues must first be tackled, including formation of a layer of endothelial cells to line graft blood vessels," he says. "Given enough careful work, this approach could ultimately revolutionize tissue engineering and provide real working grafts for the liver and other complex tissues." Yarmush and Korkut Uygun both have faculty appointments at Harvard Medical School.
Additional co-authors of the Nature Medicine report are Alejandro Soto-Gutierrez, MD, PhD, Hiroshi Yagi, MD, Maria-Louisa Izamis, Maria Guzzardi, Carley Shulman, Jack Milwid, Arno Tilles, MD, Francois Berthiaume, PhD, and Yaahov Nahmias, PhD, MGH Center for Engineering in Medicine; Martin Hertl, MD, MGH Surgery; and Naoya Kobyashi, MD, PhD, Okayama University School of Medicine and Dentistry, Japan. The study was partially supported by grants from the National Institutes of Health, National Science Foundation and Shriners Hospitals for Children.
Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Massachusetts General Hospital, via EurekAlert! a service of AAAS.
Journal Reference:
Basak E Uygun, Alejandro Soto-Gutierrez, Hiroshi Yagi, Maria-Louisa Izamis, Maria A Guzzardi, Carley Shulman, Jack Milwid, Naoya Kobayashi, Arno Tilles, Francois Berthiaume, Martin Hertl, Yaakov Nahmias, Martin L Yarmush, Korkut Uygun. Organ reengineering through development of a transplantable recellularized liver graft using decellularized liver matrix. Nature Medicine, 2010; DOI: 10.1038/nm.2170
http://www.sciencedaily.com/releases/2010/06/100613181240.htm
June 18, 2010
A Sport Crafted for Liver Health
Find out the four characteristics of outrigger canoeing that make it a sport with a unique attribute – promoting a healthy liver.
by Nicole Cutler, L.Ac.
Considered the state sport of Hawaii, outrigger canoe racing is an activity with historical roots in Southeast Asia, Polynesia and New Zealand. Over the past few decades, outrigger canoeing has steadily grown in popularity with recreational and competitive clubs strewn across the United States. While paddling an outrigger canoe may not appeal to everyone, this water sport has a number of features that make it ideal for benefiting liver health.
What Is an Outrigger Canoe?
An outrigger canoe is a type of canoe containing one or more outriggers (lateral support floats) fastened to the side of the boat. Some characteristics of this vessel, include:
· Compared to other types of canoes, outrigger canoes can move very fast.
· Most outrigger canoes seat six people, each of whom is important to the boat’s movement.
· Having an attached outrigger increases the canoe’s stability, which reduces its tendency to capsize in rough water.
Besides the canoe itself being unique, an outrigger’s paddling technique also differs from other non-motor powered boats. Different from kayaking or rowing, the outrigger paddle is single-sided, with either a straight or a double-bend shaft. Because there isn’t a dual paddle arrangement, the paddler has to alternate sides often in order to maintain stamina and stability.
Liver Reasons to Paddle
There are several reasons that outrigger canoeing is a great choice for those wanting to support their liver’s health:
1. Cardiovascular Exercise – By preventing or even reversing fatty liver disease, and helping ease portal hypertension, cardiovascular exercise helps people maintain a healthy weight and keeps blood flowing freely throughout the body (including the liver). As a vigorous cardiovascular exercise, outrigger canoeing can burn an estimated 400 calories per hour.
2. Torso Movement – Unlike most sports, outrigger paddling recruits the body’s larger muscle groups in the mid-section – exactly where the liver is housed. Because the strength to power a canoe comes mainly from twisting the torso, there is a great deal of movement in this area. Thus, paddling puts a physical demand on the body’s mid-section, which stimulates the filling and draining of the liver, the natural process necessary for the liver to cleanse the blood.
3. Optimistic Attitude – Besides its associated physical health benefits, paddling in a river, ocean, bay or lake also initiates a positive mental and emotional shift. An active way to appreciate the outdoors, paddling can be peaceful and meditative or it can be exhilarating. In addition, the breaking of the surface tension of water (by waves, falls or a canoe) releases negative hydrogen ions into the atmosphere. One of the many reported health benefits of negative hydrogen ions is to boost serotonin levels, a surefire way to lift one’s mood.
4. No Age Limit – Because it is a low-impact activity with a rich cultural history, outrigger canoeing welcomes people of all ages. Not having an age limit can be important to those who have surpassed 30 years of age and want to get involved in a team sport. In fact, competitive outrigger racing is divided into the following categories: “Open,” which includes those aged 20 to 35 (but is open to any age), “Masters,” which includes those aged 35 to 45, “Senior Masters,” which includes those aged 45 to 55 and “Kapuna,” which includes those aged 55 and up.
Outrigger Tips
If outrigger canoeing might be the sport you are looking for, these two suggestions can help guide you further:
1. Join a Club – The best way to learn about outrigger canoeing is through a local canoe club. Besides learning the proper paddling technique, a club provides the camaraderie inherent to this sport and assures safety issues are addressed.
2. Brush Up On Swimming – Since paddling involves the occasional tip into the water, it is important to be a competent swimmer. If necessary, brush up on your swimming skills so that you can feel confident in a canoe.
If keeping your liver healthy is a priority and group water sports appeals to you, consider outrigger canoeing. Because it is a low-impact cardiovascular exercise, stimulates liver activity by moving the torso, is known to lift the mood and has no age restriction, paddling in an outrigger canoe is an ultimate activity for taking care of your liver.
References:
http://en.wikipedia.org/wiki/Outrigger_canoe , Outrigger Canoe, Retrieved July 31, 2009, Wikimedia Foundation, Inc., 2009.
http://nsmc.staywellsolutionsonline.com/Features/1,2923 , Kayak Your Way to Better Health, Retrieved July 31, 2009, North Shore Medical Center, 2009.
http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Canoeing_and_kayaking?OpenDocument , Canoeing and kayaking - health benefits, Retrieved July 31, 2009, State of Victoria, March 2009.
http://www.health-benefit-of-water.com/negative-ions.html , Water generates Negative Ions, Retrieved August 1, 2009, health-benefit-of-water.com, 2009.
http://www.sheknows.com/articles/7258.htm , Benefits of canoeing and kayaking, Retrieved July 31, 2009, SheKnows LLC, 2009.
http://www.thecancerblog.com/2006/03/08/dragon-boat-races-breast-cancer-survivors-paddle-to-prevention/ , Dragon Boat Races: breast cancer survivors paddle to prevention, Dalene Entenmann, Retrieved July 31, 2009, Weblogs, Inc., 2009.
.
http://www.liversupport.com/wordpress/2010/06/a-sport-crafted-for-liver-health/
by Nicole Cutler, L.Ac.
Considered the state sport of Hawaii, outrigger canoe racing is an activity with historical roots in Southeast Asia, Polynesia and New Zealand. Over the past few decades, outrigger canoeing has steadily grown in popularity with recreational and competitive clubs strewn across the United States. While paddling an outrigger canoe may not appeal to everyone, this water sport has a number of features that make it ideal for benefiting liver health.
What Is an Outrigger Canoe?
An outrigger canoe is a type of canoe containing one or more outriggers (lateral support floats) fastened to the side of the boat. Some characteristics of this vessel, include:
· Compared to other types of canoes, outrigger canoes can move very fast.
· Most outrigger canoes seat six people, each of whom is important to the boat’s movement.
· Having an attached outrigger increases the canoe’s stability, which reduces its tendency to capsize in rough water.
Besides the canoe itself being unique, an outrigger’s paddling technique also differs from other non-motor powered boats. Different from kayaking or rowing, the outrigger paddle is single-sided, with either a straight or a double-bend shaft. Because there isn’t a dual paddle arrangement, the paddler has to alternate sides often in order to maintain stamina and stability.
Liver Reasons to Paddle
There are several reasons that outrigger canoeing is a great choice for those wanting to support their liver’s health:
1. Cardiovascular Exercise – By preventing or even reversing fatty liver disease, and helping ease portal hypertension, cardiovascular exercise helps people maintain a healthy weight and keeps blood flowing freely throughout the body (including the liver). As a vigorous cardiovascular exercise, outrigger canoeing can burn an estimated 400 calories per hour.
2. Torso Movement – Unlike most sports, outrigger paddling recruits the body’s larger muscle groups in the mid-section – exactly where the liver is housed. Because the strength to power a canoe comes mainly from twisting the torso, there is a great deal of movement in this area. Thus, paddling puts a physical demand on the body’s mid-section, which stimulates the filling and draining of the liver, the natural process necessary for the liver to cleanse the blood.
3. Optimistic Attitude – Besides its associated physical health benefits, paddling in a river, ocean, bay or lake also initiates a positive mental and emotional shift. An active way to appreciate the outdoors, paddling can be peaceful and meditative or it can be exhilarating. In addition, the breaking of the surface tension of water (by waves, falls or a canoe) releases negative hydrogen ions into the atmosphere. One of the many reported health benefits of negative hydrogen ions is to boost serotonin levels, a surefire way to lift one’s mood.
4. No Age Limit – Because it is a low-impact activity with a rich cultural history, outrigger canoeing welcomes people of all ages. Not having an age limit can be important to those who have surpassed 30 years of age and want to get involved in a team sport. In fact, competitive outrigger racing is divided into the following categories: “Open,” which includes those aged 20 to 35 (but is open to any age), “Masters,” which includes those aged 35 to 45, “Senior Masters,” which includes those aged 45 to 55 and “Kapuna,” which includes those aged 55 and up.
Outrigger Tips
If outrigger canoeing might be the sport you are looking for, these two suggestions can help guide you further:
1. Join a Club – The best way to learn about outrigger canoeing is through a local canoe club. Besides learning the proper paddling technique, a club provides the camaraderie inherent to this sport and assures safety issues are addressed.
2. Brush Up On Swimming – Since paddling involves the occasional tip into the water, it is important to be a competent swimmer. If necessary, brush up on your swimming skills so that you can feel confident in a canoe.
If keeping your liver healthy is a priority and group water sports appeals to you, consider outrigger canoeing. Because it is a low-impact cardiovascular exercise, stimulates liver activity by moving the torso, is known to lift the mood and has no age restriction, paddling in an outrigger canoe is an ultimate activity for taking care of your liver.
References:
http://en.wikipedia.org/wiki/Outrigger_canoe , Outrigger Canoe, Retrieved July 31, 2009, Wikimedia Foundation, Inc., 2009.
http://nsmc.staywellsolutionsonline.com/Features/1,2923 , Kayak Your Way to Better Health, Retrieved July 31, 2009, North Shore Medical Center, 2009.
http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Canoeing_and_kayaking?OpenDocument , Canoeing and kayaking - health benefits, Retrieved July 31, 2009, State of Victoria, March 2009.
http://www.health-benefit-of-water.com/negative-ions.html , Water generates Negative Ions, Retrieved August 1, 2009, health-benefit-of-water.com, 2009.
http://www.sheknows.com/articles/7258.htm , Benefits of canoeing and kayaking, Retrieved July 31, 2009, SheKnows LLC, 2009.
http://www.thecancerblog.com/2006/03/08/dragon-boat-races-breast-cancer-survivors-paddle-to-prevention/ , Dragon Boat Races: breast cancer survivors paddle to prevention, Dalene Entenmann, Retrieved July 31, 2009, Weblogs, Inc., 2009.
.
http://www.liversupport.com/wordpress/2010/06/a-sport-crafted-for-liver-health/
Splicing Diversity of the Human OCLN Gene and Its Biological Significance for Hepatitis C Virus Entry
Journal of Virology, July 2010, p. 6987-6994, Vol. 84, No. 14
0022-538X/10/$012.00+0 doi:10.1128/JVI.00196-10
Copyright © 2010, American Society for Microbiology. All Rights Reserved.
Indu Kohaar,1 Alexander Ploss,2 Evgenia Korol,2 Kathy Mu,2 John W. Schoggins,2 Thomas R. O'Brien,3 Charles M. Rice,2 and Ludmila Prokunina-Olsson1*
Laboratory of Translational Genomics,1 Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892,3 Center for the Study of Hepatitis C, Laboratory of Virology and Infectious Diseases, The Rockefeller University, 1230 York Avenue, Box 64, New York, New York 100652
Received 27 January 2010/ Accepted 29 April 2010
Persistent hepatitis C virus (HCV) infection is a primary etiological factor for the development of chronic liver disease, including cirrhosis and cancer. A recent study identified occludin (OCLN), an integral tight junction protein, as one of the key factors for HCV entry into cells. We explored the splicing diversity of OCLN in normal human liver and observed variable expression of alternative splice variants, including two known forms (WT-OCLN and OCLN-ex4del) and six novel forms (OCLN-ex7ext, OCLN-ex3pdel, OCLN-ex3del, OCLN-ex3-4del, OCLN-ex3p-9pdel, and OCLN-ex3p-7pdel). Recombinant protein isoforms WT-OCLN and OCLN-ex7ext, which retained the HCV-interacting MARVEL domain, were expressed on the cell membrane and were permissive for HCV infection in in vitro infectivity assays. All other forms lacked the MARVEL domain, were expressed in the cytoplasm, and were nonpermissive for HCV infection. Additionally, we observed variable expression of OCLN splicing forms across human tissues and cell lines. Our study suggests that the remarkable natural splicing diversity of OCLN might contribute to HCV tissue tropism and possibly modify the outcome of HCV infection in humans. Genetic factors crucial for regulation of OCLN expression and susceptibility to HCV infection remain to be elucidated.
* Corresponding author. Mailing address: Laboratory of Translational Genomics, National Cancer Institute, National Institutes of Health, 8717 Grovemont Circle, Bethesda, MD 20892-4605. Phone: (301) 443-5297. Fax: (301) 443-3234. E-mail: prokuninal@mail.nih.gov
Published ahead of print on 12 May 2010.
Supplemental material for this article may be found at http://jvi.asm.org/ .
Journal of Virology, July 2010, p. 6987-6994, Vol. 84, No. 14
0022-538X/10/$012.00+0 doi:10.1128/JVI.00196-10
Copyright © 2010, American Society for Microbiology. All Rights Reserved
http://jvi.asm.org/cgi/content/abstract/84/14/6987?view=short&fp=6987&vol=84&lookupType=volpage
0022-538X/10/$012.00+0 doi:10.1128/JVI.00196-10
Copyright © 2010, American Society for Microbiology. All Rights Reserved.
Indu Kohaar,1 Alexander Ploss,2 Evgenia Korol,2 Kathy Mu,2 John W. Schoggins,2 Thomas R. O'Brien,3 Charles M. Rice,2 and Ludmila Prokunina-Olsson1*
Laboratory of Translational Genomics,1 Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892,3 Center for the Study of Hepatitis C, Laboratory of Virology and Infectious Diseases, The Rockefeller University, 1230 York Avenue, Box 64, New York, New York 100652
Received 27 January 2010/ Accepted 29 April 2010
Persistent hepatitis C virus (HCV) infection is a primary etiological factor for the development of chronic liver disease, including cirrhosis and cancer. A recent study identified occludin (OCLN), an integral tight junction protein, as one of the key factors for HCV entry into cells. We explored the splicing diversity of OCLN in normal human liver and observed variable expression of alternative splice variants, including two known forms (WT-OCLN and OCLN-ex4del) and six novel forms (OCLN-ex7ext, OCLN-ex3pdel, OCLN-ex3del, OCLN-ex3-4del, OCLN-ex3p-9pdel, and OCLN-ex3p-7pdel). Recombinant protein isoforms WT-OCLN and OCLN-ex7ext, which retained the HCV-interacting MARVEL domain, were expressed on the cell membrane and were permissive for HCV infection in in vitro infectivity assays. All other forms lacked the MARVEL domain, were expressed in the cytoplasm, and were nonpermissive for HCV infection. Additionally, we observed variable expression of OCLN splicing forms across human tissues and cell lines. Our study suggests that the remarkable natural splicing diversity of OCLN might contribute to HCV tissue tropism and possibly modify the outcome of HCV infection in humans. Genetic factors crucial for regulation of OCLN expression and susceptibility to HCV infection remain to be elucidated.
* Corresponding author. Mailing address: Laboratory of Translational Genomics, National Cancer Institute, National Institutes of Health, 8717 Grovemont Circle, Bethesda, MD 20892-4605. Phone: (301) 443-5297. Fax: (301) 443-3234. E-mail: prokuninal@mail.nih.gov
Published ahead of print on 12 May 2010.
Supplemental material for this article may be found at http://jvi.asm.org/ .
Journal of Virology, July 2010, p. 6987-6994, Vol. 84, No. 14
0022-538X/10/$012.00+0 doi:10.1128/JVI.00196-10
Copyright © 2010, American Society for Microbiology. All Rights Reserved
http://jvi.asm.org/cgi/content/abstract/84/14/6987?view=short&fp=6987&vol=84&lookupType=volpage
HCV Rapidly Develops Resistance to Directing-acting Agents, Indicating Need for Multidrug Combos
SUMMARY: The hepatitis C virus (HCV) can rapidly develop mutations that confer resistance to multiple direct-acting agents such as HCV protease and polymerase inhibitors, according to a mathematical model described in the May 5, 2010 edition of Science Translational Medicine. Researchers suggested that effective oral therapy without interferon may require as many as 4 complementary drugs to avoid resistance.
Standard therapy for chronic hepatitis C using pegylated interferon plus ribavirin can cause difficult side effects and only clears the virus about half the time, leading researchers to evaluate a large number of direct-acting oral drugs that target specific steps of the viral lifecycle.
But HCV mutates easily and rapidly as it replicates, which allows for emergence of drug resistance mutations. Recent research indicates that resistance mutations are common, and in order for these agents to have prolonged effectiveness without interferon, some people may require "cocktails" of as many as 4 drugs that work in different ways.
Below is the text of a press release issued by the University of Illinois at Chicago summarizing the modeling study.
Combination of Direct Antivirals May Be Key to Curing Hep C
Chicago -- May 5, 2010 -- A combination of antiviral drugs may be needed to combat the drug resistance that rapidly develops in potentially deadly hepatitis C infections, a new study using sophisticated computer and mathematical modeling has shown.
Using probabilistic and viral dynamic models, researchers at the University of Illinois at Chicago, Oakland University and Los Alamos National Laboratory predict why rapid resistance emerges in hepatitis C virus and show that a combination of drugs that can fight three or more mutated strains may be needed to eradicate the virus from the body. They compared their model with data from a clinical trial of the new direct-acting antiviral medication telaprevir.
The findings are published in Science Translational Medicine.
Hepatitis C is a progressive liver disease that can lead to cirrhosis and liver cancer. Current standard treatment is a combination of the antiviral drugs interferon and ribavirin for a period of 24 to 48 weeks -- a regimen that is long and expensive, carries side effects, and is successful only in about half of patients.
Intensive effort has focused on developing direct antiviral drugs. But the virus is genetically diverse, and so may be particularly prone to develop resistance, said Harel Dahari, research assistant professor of hepatology in the UIC College of Medicine and one of the paper's co-authors.
One way to combat resistance would be to administer multiple drugs, each with a different mechanism of inhibiting the virus.
"We found that rapid emergence of resistance to these types of drugs is due to a population of viruses already present, allowing the resistant virus to become the dominant strain," said Dahari.
The researchers suggest that a combination of new antiviral drugs will be needed to fight all of the resistant virus strains and achieve better cure rates for the disease.
"We are moving to a new era where we can treat these patients with direct-acting agents against the virus, in which we specifically target the life-cycle of the virus," Dahari said.
To replace the standard treatment, four or more different types of direct drugs may be needed, Dahari said. However, some patients may need fewer drugs. It depends on the level of the virus in their blood, among other factors.
It is frustrating for patients to go through a long, difficult treatment and know that they might not be cured, said Dr. Scott Cotler, associate professor of medicine at UIC and a hepatologist who treats patients at the University of Illinois Medical Center's Walter Payton Liver Center.
"Patients are looking forward to a day when they don't have to take interferon and ribavirin," said Cotler. "But as we are learning with this study, if we are going to need four different direct drugs, it is going to be awhile before we get there. Now at least we know where the goal line is."
Dahari suggests that future treatment that includes the standard treatment and direct antivirals, such as telaprevir or boceprevir, will be tailored to each patient and that using direct antivirals may also shorten the duration of treatment.
Investigator affiliations: Theoretical Biology and Biophysics, Los Alamos National Laboratory, Los Alamos, NM; Department of Mathematics and Statistics and Center for Biomedical Research, Oakland University, Rochester, MI; Department of Medicine, University of Illinois, Chicago, IL.
6/18/10
Source
University of Illinois at Chicago. HCV Rapidly Develops Resistance to Directing-acting Agents Indicating Need for Multidrug Combos. Press release. May 5, 2010.
References
L Rong, H Dahari, RM Ribeiro, and others. Rapid Emergence of Protease Inhibitor Resistance in Hepatitis C Virus. Science Translational Medicine 2(30): 30ra32 (Abstract). May 5, 2010.
DL Wyles and RT Schooley. Rong's Numbers: Accelerating Progress in HCV Therapeutic Research (Editorial). Science Translational Medicine 2(33):33ps25. May 26, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0618_2010_b.html
Standard therapy for chronic hepatitis C using pegylated interferon plus ribavirin can cause difficult side effects and only clears the virus about half the time, leading researchers to evaluate a large number of direct-acting oral drugs that target specific steps of the viral lifecycle.
But HCV mutates easily and rapidly as it replicates, which allows for emergence of drug resistance mutations. Recent research indicates that resistance mutations are common, and in order for these agents to have prolonged effectiveness without interferon, some people may require "cocktails" of as many as 4 drugs that work in different ways.
Below is the text of a press release issued by the University of Illinois at Chicago summarizing the modeling study.
Combination of Direct Antivirals May Be Key to Curing Hep C
Chicago -- May 5, 2010 -- A combination of antiviral drugs may be needed to combat the drug resistance that rapidly develops in potentially deadly hepatitis C infections, a new study using sophisticated computer and mathematical modeling has shown.
Using probabilistic and viral dynamic models, researchers at the University of Illinois at Chicago, Oakland University and Los Alamos National Laboratory predict why rapid resistance emerges in hepatitis C virus and show that a combination of drugs that can fight three or more mutated strains may be needed to eradicate the virus from the body. They compared their model with data from a clinical trial of the new direct-acting antiviral medication telaprevir.
The findings are published in Science Translational Medicine.
Hepatitis C is a progressive liver disease that can lead to cirrhosis and liver cancer. Current standard treatment is a combination of the antiviral drugs interferon and ribavirin for a period of 24 to 48 weeks -- a regimen that is long and expensive, carries side effects, and is successful only in about half of patients.
Intensive effort has focused on developing direct antiviral drugs. But the virus is genetically diverse, and so may be particularly prone to develop resistance, said Harel Dahari, research assistant professor of hepatology in the UIC College of Medicine and one of the paper's co-authors.
One way to combat resistance would be to administer multiple drugs, each with a different mechanism of inhibiting the virus.
"We found that rapid emergence of resistance to these types of drugs is due to a population of viruses already present, allowing the resistant virus to become the dominant strain," said Dahari.
The researchers suggest that a combination of new antiviral drugs will be needed to fight all of the resistant virus strains and achieve better cure rates for the disease.
"We are moving to a new era where we can treat these patients with direct-acting agents against the virus, in which we specifically target the life-cycle of the virus," Dahari said.
To replace the standard treatment, four or more different types of direct drugs may be needed, Dahari said. However, some patients may need fewer drugs. It depends on the level of the virus in their blood, among other factors.
It is frustrating for patients to go through a long, difficult treatment and know that they might not be cured, said Dr. Scott Cotler, associate professor of medicine at UIC and a hepatologist who treats patients at the University of Illinois Medical Center's Walter Payton Liver Center.
"Patients are looking forward to a day when they don't have to take interferon and ribavirin," said Cotler. "But as we are learning with this study, if we are going to need four different direct drugs, it is going to be awhile before we get there. Now at least we know where the goal line is."
Dahari suggests that future treatment that includes the standard treatment and direct antivirals, such as telaprevir or boceprevir, will be tailored to each patient and that using direct antivirals may also shorten the duration of treatment.
Investigator affiliations: Theoretical Biology and Biophysics, Los Alamos National Laboratory, Los Alamos, NM; Department of Mathematics and Statistics and Center for Biomedical Research, Oakland University, Rochester, MI; Department of Medicine, University of Illinois, Chicago, IL.
6/18/10
Source
University of Illinois at Chicago. HCV Rapidly Develops Resistance to Directing-acting Agents Indicating Need for Multidrug Combos. Press release. May 5, 2010.
References
L Rong, H Dahari, RM Ribeiro, and others. Rapid Emergence of Protease Inhibitor Resistance in Hepatitis C Virus. Science Translational Medicine 2(30): 30ra32 (Abstract). May 5, 2010.
DL Wyles and RT Schooley. Rong's Numbers: Accelerating Progress in HCV Therapeutic Research (Editorial). Science Translational Medicine 2(33):33ps25. May 26, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0618_2010_b.html
Idenix Begins Proof-of-Concept Study of HCV Protease Inhibitor IDX320
SUMMARY: Idenix Pharmaceuticals announced last week that it has started a 3-day proof-of-concept study of its experimental hepatitis C virus (HCV) protease inhibitor IDX320. As previously reported, researchers presented data at the recent EASL conference showing that IDX320 showed good anti-HCV activity in laboratory studies and had good pharmacokinetic and safety profiles in animals and HCV negative volunteers. If the latest study produces favorable results, the company expects to test IDX320 and its investigational HCV polymerase inhibitor IDX184 as a combination regimen.
Below is an excerpt from a recent Idenix press release describing the drugs and the new study.
Idenix Pharmaceuticals Initiates Proof-of-Concept Study for Protease Inhibitor IDX320 in Hepatitis C Patients
Cambridge, Mass. -- June 10, 2010 -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has initiated a 3-day proof-of-concept study of IDX320, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection, under a Clinical Trial Application (CTA). The study is evaluating IDX320 in treatment-naive hepatitis C genotype 1-infected patients.
"The potent and multi-genotypic activity demonstrated in vitro, as well as the favorable pharmacokinetics observed in healthy volunteers, suggests a promising profile for further development of IDX320," said Jean-Pierre Sommadossi, PhD, chief executive officer of Idenix. "The landscape for combination development in HCV is evolving quickly. Assuming favorable results from the IDX320 proof-of-concept study, we plan to discuss with regulatory agencies a direct-acting antiviral combination strategy with IDX320 and IDX184, our HCV nucleotide polymerase inhibitor."
Douglas Mayers, MD, Idenix's chief medical officer commented, "We are encouraged by the results seen to date with IDX320 and are hopeful that future clinical studies will allow us to continue advancing this program with the ultimate goal of treating a wide range of patients infected with HCV."
The proof-of-concept trial in HCV-infected patients is a Phase I/II randomized, parallel-arm, double-blind, placebo-controlled study evaluating the safety and antiviral activity of IDX320 in treatment-naive adult patients infected with chronic hepatitis C. The study will evaluate four doses of IDX320, ranging from 50 to 400 mg once-per-day, administered for three days. Each cohort of the study will evaluate eight patients randomized six to IDX320 and two to placebo.
About IDX320
IDX320, a macrocyclic HCV protease inhibitor, is an inhibitor of NS3/4A proteases from genotypes 1a, 1b, 2a and 4a (IC50 values from 0.8 to 1.9 nM), as well as from genotype 3a (IC50=23 nM). IDX320 did not inhibit nine tested cellular proteases (IC50 > 10 uM) in vitro, suggesting high selectivity. IDX320 bound tightly to the HCV protease enzyme with a long dissociation half-life (> 9 hours). After single 2 mg/kg oral doses of IDX320 in two animal species, favorable bioavailability and a long plasma half-life were observed, with substantial plasma concentrations 24 hours post dose. Comparable drug exposure was confirmed in healthy volunteers (n=6) receiving a single 200 mg oral dose. Further, no significant in vitro inhibition of human drug metabolizing enzymes, CYP450s and UGT1A1, by IDX320 suggests low potential for drug-drug interactions in patients.
About IDX184
IDX184 is a novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine monophosphate, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. IDX184 in combination with pegylated interferon and ribavirin has demonstrated a generally favorable safety profile and potent antiviral activity in an ongoing Phase IIa study.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with chronic hepatitis C infection.
For further information about Idenix, please refer to http://www.idenix.com/ .
6/8/10
Source
Idenix Pharmaceuticals. Idenix Pharmaceuticals Initiates Proof-of-Concept Study for Protease Inhibitor IDX320 in Hepatitis C Patients. Press release. June 10, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0618_2010_a.html
Below is an excerpt from a recent Idenix press release describing the drugs and the new study.
Idenix Pharmaceuticals Initiates Proof-of-Concept Study for Protease Inhibitor IDX320 in Hepatitis C Patients
Cambridge, Mass. -- June 10, 2010 -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has initiated a 3-day proof-of-concept study of IDX320, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection, under a Clinical Trial Application (CTA). The study is evaluating IDX320 in treatment-naive hepatitis C genotype 1-infected patients.
"The potent and multi-genotypic activity demonstrated in vitro, as well as the favorable pharmacokinetics observed in healthy volunteers, suggests a promising profile for further development of IDX320," said Jean-Pierre Sommadossi, PhD, chief executive officer of Idenix. "The landscape for combination development in HCV is evolving quickly. Assuming favorable results from the IDX320 proof-of-concept study, we plan to discuss with regulatory agencies a direct-acting antiviral combination strategy with IDX320 and IDX184, our HCV nucleotide polymerase inhibitor."
Douglas Mayers, MD, Idenix's chief medical officer commented, "We are encouraged by the results seen to date with IDX320 and are hopeful that future clinical studies will allow us to continue advancing this program with the ultimate goal of treating a wide range of patients infected with HCV."
The proof-of-concept trial in HCV-infected patients is a Phase I/II randomized, parallel-arm, double-blind, placebo-controlled study evaluating the safety and antiviral activity of IDX320 in treatment-naive adult patients infected with chronic hepatitis C. The study will evaluate four doses of IDX320, ranging from 50 to 400 mg once-per-day, administered for three days. Each cohort of the study will evaluate eight patients randomized six to IDX320 and two to placebo.
About IDX320
IDX320, a macrocyclic HCV protease inhibitor, is an inhibitor of NS3/4A proteases from genotypes 1a, 1b, 2a and 4a (IC50 values from 0.8 to 1.9 nM), as well as from genotype 3a (IC50=23 nM). IDX320 did not inhibit nine tested cellular proteases (IC50 > 10 uM) in vitro, suggesting high selectivity. IDX320 bound tightly to the HCV protease enzyme with a long dissociation half-life (> 9 hours). After single 2 mg/kg oral doses of IDX320 in two animal species, favorable bioavailability and a long plasma half-life were observed, with substantial plasma concentrations 24 hours post dose. Comparable drug exposure was confirmed in healthy volunteers (n=6) receiving a single 200 mg oral dose. Further, no significant in vitro inhibition of human drug metabolizing enzymes, CYP450s and UGT1A1, by IDX320 suggests low potential for drug-drug interactions in patients.
About IDX184
IDX184 is a novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine monophosphate, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. IDX184 in combination with pegylated interferon and ribavirin has demonstrated a generally favorable safety profile and potent antiviral activity in an ongoing Phase IIa study.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with chronic hepatitis C infection.
For further information about Idenix, please refer to http://www.idenix.com/ .
6/8/10
Source
Idenix Pharmaceuticals. Idenix Pharmaceuticals Initiates Proof-of-Concept Study for Protease Inhibitor IDX320 in Hepatitis C Patients. Press release. June 10, 2010.
http://www.hivandhepatitis.com/hep_c/news/2010/0618_2010_a.html
WHEN GOOD DRUGS DO BAD THINGS
If your organs had a personality, your liver would be the strong, silent type. No matter how hard it works at filtering out toxins like alcohol and drugs, it doesn't complain until it's on the verge of collapse. And when we say drugs, we don't mean the illegal kind. We're talking about the dozens of meds with liver-damage potential. The weight-loss aid called orlistat - aka Xenical and Alli - is the latest med that has to include liver cautions on its label. Luckily for us and you, the liver has a remarkable ability to give itself a makeover. So if you do have a DILI (drug-induced liver injury), stopping the med and treating your liver right - no alcohol, for starters - usually will restore it to health, as long as it was in good shape to begin with. But since the liver isn't a whiner, the trick is to spot the damage before it makes your skin itch and turns your eyeballs yellow, your pee dark and your poop pale. Some DILI-defending tips: Read the fine print. You know those package inserts with the tiny type. Get out your magnifier and read it. Cautions about liver damage will make you more alert to warning signs (below). Don't ignore vague symptoms. Nausea, poor appetite, malaise and just not feeling great - especially shortly after starting a medication - can precede the obvious symptoms. Get the tests. Liver-function tests are advised even before treatment begins with some meds, such as terbinafine (e.g., Lamisil), the nail fungus drug. Don't blow them off.
http://telegraphjournal.canadaeast.com/magazine/article/1090306
http://telegraphjournal.canadaeast.com/magazine/article/1090306
Blueberries may benefit people with liver diseases
2010-06-18 15:30:00
Last Updated: 2010-06-18 16:11:33
Washington: A new research indicates that blueberries could provide relief to patients suffering from liver diseases - especially hepatic fibrosis.
A study led by Ming-Liang Cheng, MD, from Department of Infectious Diseases, Guiyang Medical College, Guiyang, presented some data from their research on the effectiveness of blueberries on liver fibrosis induced in laboratory animals.
The study shows that blueberries could reduce liver indices, serum levels of hyaluronic acid and alanine aminotransferase, and increase levels of superoxide dismutase and decrease levels of malondialdehyde in liver homogenates compared with the model group. The stage of hepatic fibrosis was also significantly weakened.
The authors suggest that blueberry consumption is beneficial for hepatic diseases including fibrosis.
The study will be published on June 7, 2010 in the World Journal of Gastroenterology.
http://sify.com/news/blueberries-may-benefit-people-with-liver-diseases-news-international-kgsp4djaeef.html
Last Updated: 2010-06-18 16:11:33
Washington: A new research indicates that blueberries could provide relief to patients suffering from liver diseases - especially hepatic fibrosis.
A study led by Ming-Liang Cheng, MD, from Department of Infectious Diseases, Guiyang Medical College, Guiyang, presented some data from their research on the effectiveness of blueberries on liver fibrosis induced in laboratory animals.
The study shows that blueberries could reduce liver indices, serum levels of hyaluronic acid and alanine aminotransferase, and increase levels of superoxide dismutase and decrease levels of malondialdehyde in liver homogenates compared with the model group. The stage of hepatic fibrosis was also significantly weakened.
The authors suggest that blueberry consumption is beneficial for hepatic diseases including fibrosis.
The study will be published on June 7, 2010 in the World Journal of Gastroenterology.
http://sify.com/news/blueberries-may-benefit-people-with-liver-diseases-news-international-kgsp4djaeef.html
Improving HCV Response With Insulin Resistance
June 9, 2010
Could insulin resistance be getting in the way of your Hepatitis C treatment? To manage this possible complication, discover why many experts advise prescribing medications to manage insulin resistance in an effort to improve Hepatitis C treatment outcomes.
by Nicole Cutler, L.Ac.
Occurring in up to half of American adults, insulin resistance describes when the body can't properly use insulin to maintain normal blood sugar levels. Unfortunate for those affected, research has consistently shown that those with Hepatitis C infection and insulin resistance are more likely to suffer from liver disease progression. Thus, scientists around the globe have been focusing on how to improve the therapeutic outcome of those with insulin resistance who are battling the Hepatitis C virus.
In their search for a common denominator uniting the growing prevalence of obesity, fatty liver disease, congestive heart failure, high cholesterol, elevated blood pressure and diabetes mellitus, health officials agree that insulin resistance appears to fit the profile. Generalized descriptions of the events that lead to insulin resistance are described below:
· Released by the pancreas, insulin is dispersed into the bloodstream in response to elevated blood sugar (glucose) levels.
· By pushing glucose out of the bloodstream and into the body's cells, insulin keeps blood glucose levels from becoming too elevated and allows cells to convert glucose into energy.
· Insulin-resistant cells do not allow for the proper conversion of glucose into energy, resulting in fatigue.
· This resistance to insulin does not permit glucose to enter the cells but, rather, causes it to accumulate in the blood.
· In an attempt to reduce the glucose levels in the blood, the body signals the pancreas to produce and release even more insulin.
· The cycle of insulin-resistant cells causes even more insulin to be released, resulting in high blood insulin levels, which could potentially develop into Type 2 diabetes mellitus.
Several studies have shown that people with chronic Hepatitis C are more likely to have insulin resistance or diabetes than those without Hepatitis C. In addition, insulin resistance is associated with a poorer response to interferon-based therapy. To manage this complication, many experts advise prescribing medications to manage insulin resistance in an effort to improve Hepatitis C treatment outcomes.
As revealed at the 2008 American Association for the Study of Liver Diseases Meeting and published in the August 2009 edition of Hepatology, Spanish researchers found that metformin improved virologic response when added to Hepatitis C interferon-ribavirin therapy in those with insulin resistance. Also known by one of its brand names Glucophage, metformin is an oral medication that helps lower blood sugar in three ways:
1. It lowers the amount of glucose absorbed from food.
2. It lowers the amount of glucose produced by the liver.
3. It increases the body's response to insulin.
Led by Manuel Romero-Gomez, MD, of Valme University Hospital in Seville, 123 patients with genotype 1 Hepatitis C and insulin resistance [homeostasis model of insulin resistance (HOMA) greater than 2] received standard peginterferon-alpha-2a/ribavirin antiviral therapy plus metformin or matching placebo. After six months, the following was determined:
· 67.4 percent of the metformin group had sustained virologic response compared with 49.1 percent of the placebo group
· 57.7 percent of women in the metformin group had sustained virologic response compared with 28.6 percent of women in the placebo group
While the participants who received triple drug therapy (metformin + pegylated interferon + ribavirin) had a better outcome than those without metformin, women had a more dramatic reduction in their viral levels than men.
Adding metformin to antiviral combination therapy may not be the solution for everyone with insulin resistance and Hepatitis C infection. However, Romero-Gomez's research further confirms that taking steps toward maintaining healthy blood sugar levels hinders liver disease progression and increases the likelihood of beating the Hepatitis C virus.
References:
http://www.healthrenewal.org/nhrblog/?p=67 , Over 50% of Americans Have Insulin Resistance - Do You?, Dr. Patrick Nemecheck, Retrieved November 28, 2009, healthrenewal.org, 2009.
http://www.hivandhepatitis.com/2008icr/aasld/docs/112108_a.html, Therapies to Manage Insulin Resistance Improve Response to Interferon-based Therapy in Chronic Hepatitis C Patients, Liz Highleyman, Retrieved November 28, 2009, hivandhepatitis.com, 2009.
http://www.liversupport.com/wordpress/2007/08/the-natural-supplement-for-metabolic-health/ , The Natural Supplement for Metabolic Health, Nicole Cutler, L.Ac., Retreived November 28, 2009, Natural Wellness, 2009.
http://www.medpagetoday.com/Gastroenterology/Hepatitis/3450 , Fat Gets in the Way of Hepatitis C Therapy, Neil Osterweil, Retrieved November 24, 2009, MedPage Today, LLC, 2009.
http://www.medpagetoday.com/MeetingCoverage/AASLD/11662 , AASLD: Metformin Effective Add-On in HCV Treatment, Charles Bankhead, Retrieved November 24, 2009, MedPage Today, LLC, 2009.
http://www.ncbi.nlm.nih.gov/pubmed/19845037 , Treatment of insulin resistance with metformin in naïve genotype 1 chronic hepatitis C patients receiving peginterferon alfa-2a plus ribavirin, Romero-Gomez M, et al, Retrieved November 25, 2009, Hepatology, August 2009.
http://www.hepatitis-central.com/mt/archives/2010/06/improving_hcv_r.html
Could insulin resistance be getting in the way of your Hepatitis C treatment? To manage this possible complication, discover why many experts advise prescribing medications to manage insulin resistance in an effort to improve Hepatitis C treatment outcomes.
by Nicole Cutler, L.Ac.
Occurring in up to half of American adults, insulin resistance describes when the body can't properly use insulin to maintain normal blood sugar levels. Unfortunate for those affected, research has consistently shown that those with Hepatitis C infection and insulin resistance are more likely to suffer from liver disease progression. Thus, scientists around the globe have been focusing on how to improve the therapeutic outcome of those with insulin resistance who are battling the Hepatitis C virus.
In their search for a common denominator uniting the growing prevalence of obesity, fatty liver disease, congestive heart failure, high cholesterol, elevated blood pressure and diabetes mellitus, health officials agree that insulin resistance appears to fit the profile. Generalized descriptions of the events that lead to insulin resistance are described below:
· Released by the pancreas, insulin is dispersed into the bloodstream in response to elevated blood sugar (glucose) levels.
· By pushing glucose out of the bloodstream and into the body's cells, insulin keeps blood glucose levels from becoming too elevated and allows cells to convert glucose into energy.
· Insulin-resistant cells do not allow for the proper conversion of glucose into energy, resulting in fatigue.
· This resistance to insulin does not permit glucose to enter the cells but, rather, causes it to accumulate in the blood.
· In an attempt to reduce the glucose levels in the blood, the body signals the pancreas to produce and release even more insulin.
· The cycle of insulin-resistant cells causes even more insulin to be released, resulting in high blood insulin levels, which could potentially develop into Type 2 diabetes mellitus.
Several studies have shown that people with chronic Hepatitis C are more likely to have insulin resistance or diabetes than those without Hepatitis C. In addition, insulin resistance is associated with a poorer response to interferon-based therapy. To manage this complication, many experts advise prescribing medications to manage insulin resistance in an effort to improve Hepatitis C treatment outcomes.
As revealed at the 2008 American Association for the Study of Liver Diseases Meeting and published in the August 2009 edition of Hepatology, Spanish researchers found that metformin improved virologic response when added to Hepatitis C interferon-ribavirin therapy in those with insulin resistance. Also known by one of its brand names Glucophage, metformin is an oral medication that helps lower blood sugar in three ways:
1. It lowers the amount of glucose absorbed from food.
2. It lowers the amount of glucose produced by the liver.
3. It increases the body's response to insulin.
Led by Manuel Romero-Gomez, MD, of Valme University Hospital in Seville, 123 patients with genotype 1 Hepatitis C and insulin resistance [homeostasis model of insulin resistance (HOMA) greater than 2] received standard peginterferon-alpha-2a/ribavirin antiviral therapy plus metformin or matching placebo. After six months, the following was determined:
· 67.4 percent of the metformin group had sustained virologic response compared with 49.1 percent of the placebo group
· 57.7 percent of women in the metformin group had sustained virologic response compared with 28.6 percent of women in the placebo group
While the participants who received triple drug therapy (metformin + pegylated interferon + ribavirin) had a better outcome than those without metformin, women had a more dramatic reduction in their viral levels than men.
Adding metformin to antiviral combination therapy may not be the solution for everyone with insulin resistance and Hepatitis C infection. However, Romero-Gomez's research further confirms that taking steps toward maintaining healthy blood sugar levels hinders liver disease progression and increases the likelihood of beating the Hepatitis C virus.
References:
http://www.healthrenewal.org/nhrblog/?p=67 , Over 50% of Americans Have Insulin Resistance - Do You?, Dr. Patrick Nemecheck, Retrieved November 28, 2009, healthrenewal.org, 2009.
http://www.hivandhepatitis.com/2008icr/aasld/docs/112108_a.html, Therapies to Manage Insulin Resistance Improve Response to Interferon-based Therapy in Chronic Hepatitis C Patients, Liz Highleyman, Retrieved November 28, 2009, hivandhepatitis.com, 2009.
http://www.liversupport.com/wordpress/2007/08/the-natural-supplement-for-metabolic-health/ , The Natural Supplement for Metabolic Health, Nicole Cutler, L.Ac., Retreived November 28, 2009, Natural Wellness, 2009.
http://www.medpagetoday.com/Gastroenterology/Hepatitis/3450 , Fat Gets in the Way of Hepatitis C Therapy, Neil Osterweil, Retrieved November 24, 2009, MedPage Today, LLC, 2009.
http://www.medpagetoday.com/MeetingCoverage/AASLD/11662 , AASLD: Metformin Effective Add-On in HCV Treatment, Charles Bankhead, Retrieved November 24, 2009, MedPage Today, LLC, 2009.
http://www.ncbi.nlm.nih.gov/pubmed/19845037 , Treatment of insulin resistance with metformin in naïve genotype 1 chronic hepatitis C patients receiving peginterferon alfa-2a plus ribavirin, Romero-Gomez M, et al, Retrieved November 25, 2009, Hepatology, August 2009.
http://www.hepatitis-central.com/mt/archives/2010/06/improving_hcv_r.html
Dude, We're running for Beaux and organ donation
Amy Donaldson
sports writer
June 18, 2010 at 9:52 a.m.
Running is hard.
It's also invigorating, refreshing and sometimes you feel so good, it almost feels like flying.
But always, there are moments that test your will, your desire, your determination. Many times you question your sanity.
And that's why taking those steps into the wind, uphill or just for miles and miles is so much easier with someone else in mind.
It is the team aspect that makes the Ragnar Relays unique. Running is a solitary endeavor. The decision to stop is yours. No referee can steal your perfect run. Only your own mind can cheat you.
So when I run I like to do it for someone else. I ran the Wasatch Back the first year the race existed, and I had never run more than a 5K at the time. It changed the way I viewed running, myself and other people. Running in the rain, alone at night, I struggled with quitting for the first time. I couldn't bring myself to give up, however, because of my abnormally upbeat teammates cheering me on. I couldn't let them down.
Every year since, and in most races, I run with someone else in my heart.
This year, our entire team - Dude, Where's My Van? - will run for a man named Beaux. None of us know him very well, but we work with his wife - Lois. What I did know of him was the usual stories colleagues offer about the men who support them, the children that make them smile. I also was recently introduced to his talent for photography. He has a website where he posts his pictures, which are, pure and simply amazing. He has a unique and beautiful perspective on life that manifests itself in his art. (http://reflectivelens.blogspot.com/)
Beaux , 49, is the father of two gorgeous girls. He was told two years ago that he'd need a new liver. After a horrific bicycle accident as a child that required more than a dozen blood transfusions, he developed Hepatitis C. He didn't know it until constant stomach aches sent him to the doctors.
Lois recently told us he'd been moved up the transplant list - a moment that gives a family hope and brings home the gravity of the diagnosis.
I was nervous about asking Lois if this group of very marginal athletes could run in her husband's honor and in hopes of raising awareness about organ donation. I mean, if you get the chance to be represented, you want it to be the person who wins. You want to have your name on Lance Armstrong's shirt, not Amy "the queen of shuffling" Donaldson's race bib.
He didn't just say yes. He was as honored to have us represent him as we are to run in his name.
He wrote a beautiful blog about our offer and his feelings, which I hope you visit.
Blog: The Paradox Syndrome
Post: Ragnar Relay's Wasatch Back
Link: theparadoxsyndrome.blogspot.com
And then I hope you take some time to consider organ donation. I know of another friend whose husband is waiting for kidneys. If you have the opportunity to offer life to a stranger, please take it. It is one last gesture of love that we can offer as members of the only team that really counts.
http://www.deseretnews.com/blog/68/10009307/Reasons-to-Run-Dude-Were-running-for-Beaux-and-organ-donation.html
sports writer
June 18, 2010 at 9:52 a.m.
Running is hard.
It's also invigorating, refreshing and sometimes you feel so good, it almost feels like flying.
But always, there are moments that test your will, your desire, your determination. Many times you question your sanity.
And that's why taking those steps into the wind, uphill or just for miles and miles is so much easier with someone else in mind.
It is the team aspect that makes the Ragnar Relays unique. Running is a solitary endeavor. The decision to stop is yours. No referee can steal your perfect run. Only your own mind can cheat you.
So when I run I like to do it for someone else. I ran the Wasatch Back the first year the race existed, and I had never run more than a 5K at the time. It changed the way I viewed running, myself and other people. Running in the rain, alone at night, I struggled with quitting for the first time. I couldn't bring myself to give up, however, because of my abnormally upbeat teammates cheering me on. I couldn't let them down.
Every year since, and in most races, I run with someone else in my heart.
This year, our entire team - Dude, Where's My Van? - will run for a man named Beaux. None of us know him very well, but we work with his wife - Lois. What I did know of him was the usual stories colleagues offer about the men who support them, the children that make them smile. I also was recently introduced to his talent for photography. He has a website where he posts his pictures, which are, pure and simply amazing. He has a unique and beautiful perspective on life that manifests itself in his art. (http://reflectivelens.blogspot.com/)
Beaux , 49, is the father of two gorgeous girls. He was told two years ago that he'd need a new liver. After a horrific bicycle accident as a child that required more than a dozen blood transfusions, he developed Hepatitis C. He didn't know it until constant stomach aches sent him to the doctors.
Lois recently told us he'd been moved up the transplant list - a moment that gives a family hope and brings home the gravity of the diagnosis.
I was nervous about asking Lois if this group of very marginal athletes could run in her husband's honor and in hopes of raising awareness about organ donation. I mean, if you get the chance to be represented, you want it to be the person who wins. You want to have your name on Lance Armstrong's shirt, not Amy "the queen of shuffling" Donaldson's race bib.
He didn't just say yes. He was as honored to have us represent him as we are to run in his name.
He wrote a beautiful blog about our offer and his feelings, which I hope you visit.
Blog: The Paradox Syndrome
Post: Ragnar Relay's Wasatch Back
Link: theparadoxsyndrome.blogspot.com
And then I hope you take some time to consider organ donation. I know of another friend whose husband is waiting for kidneys. If you have the opportunity to offer life to a stranger, please take it. It is one last gesture of love that we can offer as members of the only team that really counts.
http://www.deseretnews.com/blog/68/10009307/Reasons-to-Run-Dude-Were-running-for-Beaux-and-organ-donation.html
EASL 45th Annual Meeting
EASL 45th Annual Meeting
(European Association for the Study of the Liver)
April 14-18, 2010
April 14-18, 2010
- New HCV Drugs EASL 2010
- From Ash To Cure - EASL April 14-18 2010
- ANTIVIRAL ACTIVITY, COMBINATION AND RESISTANCE OF ACH-1625, A POTENT HCV NS3 PROTEASE INHIBITOR
- CHARACTERIZATION OF THE HEPATOSELECTIVE DISTRIBUTION OF ACH-1625: A POTENT, CLINICAL STAGE HCV NS3 PROTEASE INHIBITOR
- VIROLOGICAL RESPONSE, SAFETY, AND PHARMACOKINETIC PROFILE FOLLOWING SINGLE - AND MULTIPLE-DOSE ADMINISTRATION OF ACH-1625 PROTEASE INHIBITOR TO HEALTHY VOLUNTEERS AND HCV GENOTYPE-1 PATIENTS
- Validation of the GeneSeq HCV NS5B Sequencing Assay for Patient-Derived HCV Subtypes 1a and 1b
- Resistance Profile Of ABT-333 And Relationship To Viral Load Decrease In Patients Treated In Combination With Peg-interferon And Ribavirin For 28 Days
- Pharmacokinetics of the HCV Polymerase Inhibitor ABT-333 in US and Japanese Healthy Volunteers
- Exposure-Viral Response Analyses of the Non-nucleoside Polymerase Inhibitor ABT-333, Following Monotherapy and ABT-333 Plus Pegylated Interferon and Ribavirin Therapy
- Pharmacokinetics of the HCV Polymerase Inhibitor ABT-072 Following Single and Multiple Dosing in Healthy Adult Volunteers
- Virologic Response Rates Following 4 Weeks of Filibuvir in Combination with Pegylated Interferon Alfa-2a and Ribavirin in Chronically-Infected HCV Genotype-1 Patients
- Genotypic Characterisation of Filibuvir Resistance in Patients Receiving Four Weeks Co-administration of Filibuvir with pegIFN/RBV(12 Week Analysis)
- Exposure-response Relationship of Filibuvir in HCV-infected Patients: Application to Dose Selection for Combination Therapy
- Impact of Sustained Virological Response After Antiviral Treatment in Chronic Hepatitis C Patients on Life Expectancy and Quality-adjusted Life-years
- Locteron, controlled-release interferon alpha 2b, 3 studies at EASL 2010 Vienna - 3 company press releases
- PHASE IIB STUDY OF BALAPIRAVIR (RG1626; NUCLEOSIDE ANALOGUE INHIBITOR OF HCV POLYMERASE) PLUS PEGINTERFERON ALFA-2A (40KD) AND RIBAVIRIN FOR CHRONIC HEPATITIS C GENOTYPE 1: FINAL RESULTS
- RANDOMIZED, OPEN-LABEL, 12-WEEK COMPARISON OF CONTROLLED-RELEASE INTERFERON ALPHA2B + RIBAVRIN VS. PEGYLATED-INTERFERON ALPHA2B + RIBAVRIN IN TREATMENT-NAïVE GENOTYPE1 HEPATITIS C: 4 WEEK RESULTS FROM 480STUDY (PANEL A)
- Slow Responders Benefit From 72 Weeks Peg/Rbv - Predicting Treatment Outcome Among Slow Responders: A Retrospective Analysis of the SUCCESS Study
- Q2week Controlled Release Interferon Alpha2b + Ribavrin Reduces Flu-like Symptoms >50% And Provides Equivalent Efficacy In Comparison To Weekly Pegylated Interferon Alpha2b + Ribavirin In Treatment-naïve Genotype-1 Chronic Hepatitis C: Results From EMPOWER, A Randomized Open-label 12-week Comparison In 133 Patients
- Early Viral Response Of Controlled-release Interferon Alpha2b And Ribavirin Vs. Pegylated-interferon Alpha2b And Ribavirin In Treatment-naïve Genotype-1 Hepatitis C: 12 Week Results (SELECT-2 Trial)
- IMPACT OF LOW-DOSE RITONAVIR BOOSTING ON THE PHARMACOKINETICS OF DANOPREVIR (RG7227; ITMN-191), A HIGHLY POTENT AND SELECTIVE INHIBITOR OF THE HCV NS3/4A PROTEASE
- High Dose Pegasys/rbv can improve SVR: Impact of higher doses of peginterferon alfa-2a and ribavirin on RVR, cEVR and SVR in HCV G1 patients with viral loads ≥400 000 IU/mL weighing ≥85 kg
- Predictors of relapse among patients treated with standard- or induction-dose peginterferon alfa-2a (40KD) combined with standard- or higher-dose ribavirin in difficult-to-cure patients
- Pegasys vs Pegintron, Baseline characteristics and on-treatment predictors of responses from real-world patient cohorts: interim results of the multinational PROPHESYS cohorts
- Metabolic Syndrome (MS) [glucose/diabetes] Is a Negative Predictor of Treatment Outcome in Patients With Chronic Hepatitis C: Results From the IDEAL Study
- Improved Inflammatory Activity With Low-Dose PegIntron (PEG) Maintenance Therapy in Prior Nonresponders With METAVIR Fibrosis Scores (MFS) of F2/F3: Final Results From the EPIC3 Program
- Characterization of resistant mutants selected in vitro by the HCV NS3/4A protease inhibitor BI 201335
- Preclinical characterization of non-covalent HCV NS3/4A protease inhibitor BI 201335
- HBsAg Kinetics of Decay and Baseline Characteristics of HBeAg-Positive Patients with Chronic Hepatitis B Following 3 Years of Tenofovir Disoproxil Fumarate (TDF) Treatment
- Evaluation of Potential Virologic Resistance in HBV Polymerase Among Subjects with Persistent Viremia Following up to 144 Weeks of Therapy with Tenofovir DF
- Efficacy of Tenofovir DF Treatment in Patients with a Suboptimal Response to Adefovir Dipivoxil
- Risk and Predictors of Mortality or Hepatocellular Carcinoma among Entecavir- or Adefovir-Treated Chronic Hepatitis B Patients with Evidence of Hepatic Decompensation
- Low Rates of Nucleos(t)ide-associated Adverse Events in the Long-term Experience with Entecavir
- MK-5172, the 1st HCV Protease Inibitor with Potent Acyivity Against Resistance Mutations In Vitro
- TMC435 & Drug Interactions: Evaluation of metabolic interactions for TMC435 via cytochrome P450 (CYP) enzymes in healthy volunteers
- EARLY ON-TREATMENT RESPONSES DURING PEGYLATED INTERFERON PLUS RIBAVIRIN ARE INCREASED FOLLOWING 13 DAYS OF COMBINATION NUCLEOSIDE POLYMERASE (RG7128) AND PROTEASE (RG7227) INHIBITOR THERAPY (INFORM-1)
- Combination of TMC435 with two novel NS5B inhibitors increases anti-HCV activity and results in a higher genetic barrier in vitro
- 4 week therapy with the non-nucleosidic polymerase inhibitor BI 207127 in combination with peginterferon alfa2A and ribavirin in treatment naïve and treatment experienced chronic HCV GT1 patients
- Pharmacokinetic-pharmacodynamic (PK-PD) analyses of TMC435 in treatment-naïve hepatitis C (HCV)-infected patients in the OPERA-1 study
- Once-daily NS5A Inhibitor (BMS-790052) Plus Peginterferon-alpha-2a And Ribavirin Produces High Rates Of Extended Rapid Virologic Response In Treatment-naïve HCV-genotype 1 Subjects: Phase 2a Trial - Bristol-Myers Squibb Study AI444014
- SILEN-C2: Early antiviral activity and safety of BI 201335 combined with peginterferon alfa-2a and ribavirin (PegIFN/RBV) in chronic HCV genotype 1 patients with non-response to PegIFN/RBV
- Phase 2 Randomized, Double-Blind Placebo-Controlled Study of Nitazoxanide with Peginterferon Alfa-2a and Ribavirin in Nonresponders with Chronic Hepatitis C Genotype 1: Final Report
- Nitazoxanide + Peg/Rbv in Nonresponders
- Combination of two complementary nucleotide analogues, PSI-7977 and PSI-938, effectively clears wild type and NS5b: S282T HCV replicons - Comparison with combinations of other antiviral compounds
- Sustained Virologic Response following RG7128 1500 mg BID PEG-IFN/RBV for 28 days in HCV Genotype 2/3 prior non-responders
- Vitamin D Supplement improve SVR in Chronic Hepatitis C (Genotype 1) Naïve Patients treated with Peg Interferon and Ribavirin
- Idenix Pharmaceuticals Reports Favorable Pharmacokinetic Data for IDX320, a Potent, Multi-Genotypic Protease Inhibitor for the Treatment of Hepatitis C
- Idenix Pharmaceuticals Reports Positive Results With IDX184 nucleoside polymerase From Interim Analysis of Phase IIa Hepatitis C Study
- Triple Combinations of Direct-Acting Antiviral Agents Demonstrate Robust Anti-HCV Activity In Vitro
- Antiviral Activity, Pharmacokinetics & Safety of IDX184 in Combination with Peg/Rbv in Treatment Naïve Genotype 1
- In Vitro Antiviral Activity of IDX320, a Novel and Potent Macrocyclic HCV Protease Inhibitor
- ANA598 HCV Polymerase Inhititor Safety & Activity + Peg/Rbv in Genotype 1
- 72% OF PATIENTS RECEIVING ANA598 IN PHASE II COMBINATION STUDY WITH INTERFERON AND RIBAVIRIN ACHIEVE UNDETECTABLE LEVELS OF VIRUS AT WEEK EIGHT
- Idenix Pharmaceuticals Reports Favorable Pharmacokinetic Data for IDX320, a Potent, Multi-Genotypic Protease Inhibitor for the Treatment of Hepatitis C
- Discrepancies Between Definitions of Null Response to Treatment with Peginterferon Alfa-2a and Ribavirin: Implications for New HCV Drug Development
- On-Treatment Response-Guided Therapy with Telaprevir q8h or q12h Combined with Peginterferon Alfa-2a or Alfa-2b and Ribavirin in Treatment-Naïve Genotype 1 Hepatitis C (Study C208)
- Activity of Telaprevir Alone or in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-naïve, Genotype 2 and 3, Hepatitis C Patients: Final Results of Study C209
- On-Treatment Response-Guided Therapy with Telaprevir q8h or q12h Combined with Peginterferon Alfa-2a or Alfa-2b and Ribavirin in Treatment-Naïve Genotype 1 Hepatitis C (Study C208)
- Idenix Pharmaceuticals Reports Positive Results With IDX184 From Interim Analysis of Phase IIa Hepatitis C Study
- Silibinin as Rescue Therapy for Suboptimal Response to Peg/Rbv
- Vitamin D Improves SVR in Naïve Genotype 1 with Peg/Rbv
- InterMune Reports Virologic Response of Ritonavir-Boosted Danoprevir (RG7227/ITMN-191) in Patients with Chronic Hepatitis C
- Identification and Characterization of PPI-461, a Potent and Selective HCV NS5A Inhibitor with Activity Against all HCV Genotypes
- Dose-Ranging, Three-Day Monotherapy Study of the HCV NS3 Protease Inhibitor GS-9256
- Long-term Outcomes Following Combination Treatment with Boceprevir plus PegIntron/Ribavirin (P/R) in Patients with Chronic Hepatitis C, Genotype 1 (CHC-G1)
- Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide Plus Peginterferon and Ribavirin in HCV Genotype 1 Naïve Patients: Week 12 Sustained Virologic Response Rate
- GlobeImmune GI-5005 HCV Product Candidate Improves Sustained Virologic Response by 10 Percent, Demonstrating Potential to Be First Therapeutic Vaccine for HCV
- Ritonavir boosting of low-dose danoprevir (RG7227; ITMN-191), HCV NS3/4A protease inhibitor, results in robust reduction in HCV RNA at lower exposures than provided by unboosted regimens
- Telaprevir in Null-Responders & Non-Responders
- VX-222 Vertex NNRTI Polymerase Inhibitor 3 Days Monotherapy
- Merck HCV Protease Inhibitor For Resistance
Lawmakers urge quick passage of bill to boost detection, treatment of hepatitis
By Julian Pecquet - 06/17/10 03:01 PM ET
Lawmakers on the House Oversight panel on Thursday urged Congress to quickly pass legislation to boost the detection and treatment of viral hepatitis, the leading cause of liver cancer in the United States.
The Oversight and Government Reform Committee held the first hearing in several years on the deadly disease, which disproportionately affects blacks and Asians, and pressed for passage of a bipartisan bill that would boost funding by $600 million over the next five years.
The hearing comes on the heels of an Institute of Medicine (IOM) report that highlighted deficiencies with the federal government's response to the epidemic. The report contains two dozen expert recommendations for improvement, including enhanced screening, physician education and the creation of a coordinated system to identify people who have the disease and refer them to care.
About 5.3 million Americans are believed to have hepatitis — the disease causes 12,000 to 15,000 deaths a year — though many don’t know it.
"The current approach [...] is not working," the IOM report says.
The legislation under consideration, introduced in October by Rep. Mike Honda (D-Calif.), has 52 bipartisan co-sponsors. The "Viral Hepatitis and Liver Cancer Control and Prevention Act" is currently in the Energy and Commerce Committee.
The bill would charge the secretary of Health and Human Services with developing and implementing a plan for the prevention, control and medical management of hepatitis B and C; it would also provide federal funding for state-based screening and early intervention programs.
Honda said the bill would eventually save billions of dollars by identifying sick people early. A study by the research firm Milliman found that without federal leadership, the cost of treating hepatitis C alone could more than triple, to $85 billion a year, by 2024.
"We can do a whole lot better than what we're doing," said Oversight panel chairman Edolphus Towns (D-N.Y.). "I think it's a disgrace to have a problem of this nature and to not commit resources."
The panel heard testimony from Honda and Reps. Bill Cassidy (R-La.) and Hank Johnson (D-Ga.). Cassidy is a hepatologist who co-sponsored the bill, and Johnson last year acknowledged he was undergoing treatment for hepatitis C.
Cassidy applauded former President Bill Clinton's children’s vaccination program and said the Honda bill would "similarly save lives." But debate quickly descended into budgetary politics.
Oversight ranking member Darrell Issa (R-Calif.) said Republicans would not vote for any new directed spending unless it's part of the budget bill, which has stalled.
Meanwhile, Democrats bristled at Issa's description of the word "earmark" to describe the bill.
A coalition of more than 175 public and private organizations launched a print ad campaign on Tuesday to coincide with the hearing. The National Viral Hepatitis Roundtable ad is made to look like a movie poster and reads "Mission: Possible."
"If Congress gets on the case now," the ad says, "the leading cause of liver cancer won't stand a chance."
Patient advocates say the Honda bill will help boost funding for hepatitis prevention efforts, which currently only get 2 percent — $19.3 million — of the budget allocated to the Centers for Disease Control and Prevention's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. Advocates hope the Honda bill will eventually allow them to get $150 million a year.
Source:
http://thehill.com/blogs/healthwatch/prescription-drug-policy/103923-lawmakers-urge-quick-passage-of-bill-to-boost-detection-treatment-of-hepatitis
Lawmakers on the House Oversight panel on Thursday urged Congress to quickly pass legislation to boost the detection and treatment of viral hepatitis, the leading cause of liver cancer in the United States.
The Oversight and Government Reform Committee held the first hearing in several years on the deadly disease, which disproportionately affects blacks and Asians, and pressed for passage of a bipartisan bill that would boost funding by $600 million over the next five years.
The hearing comes on the heels of an Institute of Medicine (IOM) report that highlighted deficiencies with the federal government's response to the epidemic. The report contains two dozen expert recommendations for improvement, including enhanced screening, physician education and the creation of a coordinated system to identify people who have the disease and refer them to care.
About 5.3 million Americans are believed to have hepatitis — the disease causes 12,000 to 15,000 deaths a year — though many don’t know it.
"The current approach [...] is not working," the IOM report says.
The legislation under consideration, introduced in October by Rep. Mike Honda (D-Calif.), has 52 bipartisan co-sponsors. The "Viral Hepatitis and Liver Cancer Control and Prevention Act" is currently in the Energy and Commerce Committee.
The bill would charge the secretary of Health and Human Services with developing and implementing a plan for the prevention, control and medical management of hepatitis B and C; it would also provide federal funding for state-based screening and early intervention programs.
Honda said the bill would eventually save billions of dollars by identifying sick people early. A study by the research firm Milliman found that without federal leadership, the cost of treating hepatitis C alone could more than triple, to $85 billion a year, by 2024.
"We can do a whole lot better than what we're doing," said Oversight panel chairman Edolphus Towns (D-N.Y.). "I think it's a disgrace to have a problem of this nature and to not commit resources."
The panel heard testimony from Honda and Reps. Bill Cassidy (R-La.) and Hank Johnson (D-Ga.). Cassidy is a hepatologist who co-sponsored the bill, and Johnson last year acknowledged he was undergoing treatment for hepatitis C.
Cassidy applauded former President Bill Clinton's children’s vaccination program and said the Honda bill would "similarly save lives." But debate quickly descended into budgetary politics.
Oversight ranking member Darrell Issa (R-Calif.) said Republicans would not vote for any new directed spending unless it's part of the budget bill, which has stalled.
Meanwhile, Democrats bristled at Issa's description of the word "earmark" to describe the bill.
A coalition of more than 175 public and private organizations launched a print ad campaign on Tuesday to coincide with the hearing. The National Viral Hepatitis Roundtable ad is made to look like a movie poster and reads "Mission: Possible."
"If Congress gets on the case now," the ad says, "the leading cause of liver cancer won't stand a chance."
Patient advocates say the Honda bill will help boost funding for hepatitis prevention efforts, which currently only get 2 percent — $19.3 million — of the budget allocated to the Centers for Disease Control and Prevention's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention. Advocates hope the Honda bill will eventually allow them to get $150 million a year.
Source:
http://thehill.com/blogs/healthwatch/prescription-drug-policy/103923-lawmakers-urge-quick-passage-of-bill-to-boost-detection-treatment-of-hepatitis
Getz Pharma to launch therapy for Hepatitis C patients
* Biotechnology-based drug for hepatitis C will be manufactured by a Pakistani company for the first time
By Irfan Aligi
KARACHI: Getz Pharma would launch the Pegylated Interferon therapy for the treatment of hepatitis C in Pakistan. The new therapy would be highly cost-effective and easy to use as the manufacturer and presenters of the new therapy have considered patients’ care and comfort. It would also be the first time that a biotechnology-based essential drug would be manufactured by Getz Pharma, a Pakistani company. It is pertinent to mention that approximately every 20th person in Pakistan is infected with hepatitis C.
The initiative taken by Getz Pharma to invest in the local manufacturing of Pegylated Interferon (Unipeg) in the country would substantially reduce the cost of treatment for a person suffering from hepatitis C. The company has invested in research and development to formulate this molecule with the help of a team of scientists from the Netherlands, led by Dr Ben Rademaker, a PhD-holder.
Getz Pharma Managing Director and Chief Executive Officer Khalid Mehmood, during a press conference on Thursday, said the size of the country’s pharmacy market is about Rs 119 billion, which is growing by 12 to 13 percent. Henceforth, they have been able to export pharmacy goods to 45 countries around the world. The pharmacy sector in the country is the largest employment provider, with around five million people employed. Pakistan’s pharmacy industry meets 90 percent of the needs of pharmacy goods.
Pharmaceutical exports are at their highest as compared to other corporate sectors in the country and have achieved a 29 percent growth, which is four times of the country’s textile exports. Still, the country’s spending on health according to annual budgetary allocations is just 0.4 percent of the GDP, while Bangladesh is spending 0.8 percent, Khalid said.
Investment: He said Getz Pharma was set up in 1995 as a small company with only 45 employees, while today the number of its employees exceeded 2,500 worldwide, and 1,850 people in Pakistan. Getz Pharma invested Rs 4 billion in revamping existing facilities, in purchasing state-of-the-art production, quality control from 2005 to 2009. It has a plan to meet the 54 percent target of exporting medicines. According to the Federal Bureau of Revenue, Getz Pharma was the second largest taxpayer unit in terms of taxes and duties with an estimated Rs 636 million in 2009, he added.
Khalid said the company’s total investment in Pakistan was Rs 4 billion in the last three years, including investment in manufacturing technology of the first locally manufactured recombinant human insulin. It plans to invest an equal amount in the coming two years in new technologies that would result in local manufacturing of drugs that are currently being imported at high costs. It may be mentioned that Getz Pharma is the single largest exporter of pharmaceutical products from the country. It was estimated that the company’s exports account for approximately 40 percent of the country’s total pharmaceutical exports.
Dr Bernardus Rademaker, speaking on the occasion, said the analytical, toxicological and pharmacokinetic studies for Unipeg (Pegylated Interferon Alpha 2a) had been carried out in Europe, comparing it to the existing research molecule.
New era: He said in addition, bioactivity and potency had also been evaluated at the Centre for Applied Molecular Biology in Lahore, a premier institute of the Science and Technology Ministry. Specialised manufacturing and testing technology is required for manufacturing the Unipeg. He said Getz Pharma had acquired the technology at a substantial investment and a number of these tests were not currently available in the country’s pharmaceutical industry. Through this molecule, Getz Pharma would herald a new biotech era in the country, he added.
To a question, Dr Rademaker said since the molecule was not available in the US, it was not necessary to seek approval form the US FDA. He also said collaboration with Getz Pharma was not business-oriented, but it had been overwhelmingly planned that the hepatitis C affected population of the country should be provided with a cost-effective and latest mode of treatment.
Dr Rademaker holds a PhD in biotechnology from the State University Utrecht, Holland. He is the founder and CEO of InProPharma, a company specialising in technology platforms for the production of biologically active proteins. Prior to setting up his own company, Rephartox BV, a contract research company for the pharmaceutical industry, he was the director of Corporate Drug Development at the Rhein Biotech NV, Maastricht and the Green Cross Vaccine Company, Seoul, Korea. He is a member of the Dutch Pharmacological Society and is a registered pharmacologist. He has authored more than 50 scientific publications, and many regulatory affairs documents.
http://www.dailytimes.com.pk/default.asp?page=2010%5C06%5C18%5Cstory_18-6-2010_pg7_17
By Irfan Aligi
KARACHI: Getz Pharma would launch the Pegylated Interferon therapy for the treatment of hepatitis C in Pakistan. The new therapy would be highly cost-effective and easy to use as the manufacturer and presenters of the new therapy have considered patients’ care and comfort. It would also be the first time that a biotechnology-based essential drug would be manufactured by Getz Pharma, a Pakistani company. It is pertinent to mention that approximately every 20th person in Pakistan is infected with hepatitis C.
The initiative taken by Getz Pharma to invest in the local manufacturing of Pegylated Interferon (Unipeg) in the country would substantially reduce the cost of treatment for a person suffering from hepatitis C. The company has invested in research and development to formulate this molecule with the help of a team of scientists from the Netherlands, led by Dr Ben Rademaker, a PhD-holder.
Getz Pharma Managing Director and Chief Executive Officer Khalid Mehmood, during a press conference on Thursday, said the size of the country’s pharmacy market is about Rs 119 billion, which is growing by 12 to 13 percent. Henceforth, they have been able to export pharmacy goods to 45 countries around the world. The pharmacy sector in the country is the largest employment provider, with around five million people employed. Pakistan’s pharmacy industry meets 90 percent of the needs of pharmacy goods.
Pharmaceutical exports are at their highest as compared to other corporate sectors in the country and have achieved a 29 percent growth, which is four times of the country’s textile exports. Still, the country’s spending on health according to annual budgetary allocations is just 0.4 percent of the GDP, while Bangladesh is spending 0.8 percent, Khalid said.
Investment: He said Getz Pharma was set up in 1995 as a small company with only 45 employees, while today the number of its employees exceeded 2,500 worldwide, and 1,850 people in Pakistan. Getz Pharma invested Rs 4 billion in revamping existing facilities, in purchasing state-of-the-art production, quality control from 2005 to 2009. It has a plan to meet the 54 percent target of exporting medicines. According to the Federal Bureau of Revenue, Getz Pharma was the second largest taxpayer unit in terms of taxes and duties with an estimated Rs 636 million in 2009, he added.
Khalid said the company’s total investment in Pakistan was Rs 4 billion in the last three years, including investment in manufacturing technology of the first locally manufactured recombinant human insulin. It plans to invest an equal amount in the coming two years in new technologies that would result in local manufacturing of drugs that are currently being imported at high costs. It may be mentioned that Getz Pharma is the single largest exporter of pharmaceutical products from the country. It was estimated that the company’s exports account for approximately 40 percent of the country’s total pharmaceutical exports.
Dr Bernardus Rademaker, speaking on the occasion, said the analytical, toxicological and pharmacokinetic studies for Unipeg (Pegylated Interferon Alpha 2a) had been carried out in Europe, comparing it to the existing research molecule.
New era: He said in addition, bioactivity and potency had also been evaluated at the Centre for Applied Molecular Biology in Lahore, a premier institute of the Science and Technology Ministry. Specialised manufacturing and testing technology is required for manufacturing the Unipeg. He said Getz Pharma had acquired the technology at a substantial investment and a number of these tests were not currently available in the country’s pharmaceutical industry. Through this molecule, Getz Pharma would herald a new biotech era in the country, he added.
To a question, Dr Rademaker said since the molecule was not available in the US, it was not necessary to seek approval form the US FDA. He also said collaboration with Getz Pharma was not business-oriented, but it had been overwhelmingly planned that the hepatitis C affected population of the country should be provided with a cost-effective and latest mode of treatment.
Dr Rademaker holds a PhD in biotechnology from the State University Utrecht, Holland. He is the founder and CEO of InProPharma, a company specialising in technology platforms for the production of biologically active proteins. Prior to setting up his own company, Rephartox BV, a contract research company for the pharmaceutical industry, he was the director of Corporate Drug Development at the Rhein Biotech NV, Maastricht and the Green Cross Vaccine Company, Seoul, Korea. He is a member of the Dutch Pharmacological Society and is a registered pharmacologist. He has authored more than 50 scientific publications, and many regulatory affairs documents.
http://www.dailytimes.com.pk/default.asp?page=2010%5C06%5C18%5Cstory_18-6-2010_pg7_17
Benitec Limited (ASX:BLT) Granted Hepatitis C RNA Interference Patent In US
Melbourne, June 18, 2010 (ABN Newswire) - Benitec Limited (ASX:BLT) (PINK:BNIKF) are pleased to announce that US Patent 7727970 "Multiple promoter expression cassettes for simultaneous delivery of RNAi agents targeted to Hepatitis C virus" has been granted by the United States Patent and Trademark Office (USPTO). The granted claims cover the use of an RNA interference construct (with multiple promoters) to inhibit the level of Hepatitis C virus in animal cells, tissues and organs. Moreover, the USPTO has granted Benitec an additional 805 days patent term in recognition of the delays in examining the patent application. Additional related applications remain pending to extend the scope of protection.
Benitec has licensed the rights to use this patent for Hepatitis C exclusively to Tacere Therapeutics, Inc., who recently announced that Pfizer has exercised its option to further develop and commercialise Tacere's Hepatitis C Virus (HCV) compounds.
Benitec's Chief Scientific Officer, Dr Peter French said, "The grant of this patent is an important further recognition of our dominant global position in the transformational DNA-directed RNA interference field and provides increased depth and breadth to our patent portfolio. Benitec's ddRNAi-related patent estate (solely owned or licensed exclusively for humans from CSIRO) currently comprises over 100 patents and patent applications covering 20 jurisdictions, of which more than 30 are granted, accepted or allowed."
Link: http://www.abnnewswire.net/media/en/docs/63116-ASX-BLT-596073.pdf
About Benitec Limited
Benitec Limited (ASX:BLT) (PINK:BNIKF) is an Australian biotechnology company focused on licensing its extensive intellectual property portfolio and developing therapeutics to treat serious diseases using its proprietary ddRNAi technology. For additional information, please visit http://www.benitec.com/ .
Contact
Mel Bridges
Executive Director
Mob: +61-413-051-600
Email: mbridges@benitec.com
Peter French
Chief Executive Officer
Mob: +61-412-457-595
Email: pfrench@benitec.com
http://www.abnnewswire.net/press/en/63116/Benitec_Limited_(ASX:BLT)_Granted_Hepatitis_C_RNA_Interference_Patent_In_US.html
Benitec has licensed the rights to use this patent for Hepatitis C exclusively to Tacere Therapeutics, Inc., who recently announced that Pfizer has exercised its option to further develop and commercialise Tacere's Hepatitis C Virus (HCV) compounds.
Benitec's Chief Scientific Officer, Dr Peter French said, "The grant of this patent is an important further recognition of our dominant global position in the transformational DNA-directed RNA interference field and provides increased depth and breadth to our patent portfolio. Benitec's ddRNAi-related patent estate (solely owned or licensed exclusively for humans from CSIRO) currently comprises over 100 patents and patent applications covering 20 jurisdictions, of which more than 30 are granted, accepted or allowed."
Link: http://www.abnnewswire.net/media/en/docs/63116-ASX-BLT-596073.pdf
About Benitec Limited
Benitec Limited (ASX:BLT) (PINK:BNIKF) is an Australian biotechnology company focused on licensing its extensive intellectual property portfolio and developing therapeutics to treat serious diseases using its proprietary ddRNAi technology. For additional information, please visit http://www.benitec.com/ .
Contact
Mel Bridges
Executive Director
Mob: +61-413-051-600
Email: mbridges@benitec.com
Peter French
Chief Executive Officer
Mob: +61-412-457-595
Email: pfrench@benitec.com
http://www.abnnewswire.net/press/en/63116/Benitec_Limited_(ASX:BLT)_Granted_Hepatitis_C_RNA_Interference_Patent_In_US.html
Subscribe to:
Posts (Atom)